Behavioral Economic Treatment to Enhance Rural (BETTER) Living: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Behavioral Economic Treatment to Enhance Rural (BETTER) Living (NCT05235971), a randomized na study. The primary outcome is Feasibility of the Intervention - Screening.

2. Clinical Question

The trial is titled Behavioral Economic Treatment to Enhance Rural Living. Its stated purpose was to gather feedback to help develop wellness and health-behavior programs delivered by phone and text messages. The intervention descriptions indicate that the text messages included assessment and intervention messages, with up to 3 messages a day for the Episodic Future Thinking and Volitional Choice arms. Participants assigned to both approaches received both interventions by text. Monitoring Only participants received general psychoeducation.

The primary measure is the count of participants who completed an intervention phone call, with a timeframe of Day 1 of Intervention. Alcohol Consumption is listed as a secondary outcome, measured as standard drinks per person over the 2 weeks (14-days) of the intervention period. The registry record does not report detailed participant characteristics, so the population represented by the enrolled participants cannot be described more specifically from these results. Nor does the record establish whether completion of the phone call predicts later participation or captures acceptability beyond this initial feasibility measure.

3. Trial Design

NCT05235971 is listed as randomized, double-masked, and factorial, with phase recorded as NA. The registry status is COMPLETED. The sponsor is the University of Michigan. The study start date is 2022-05-17, and the primary completion date is 2023-05-08. Enrollment is listed as 75 participants.

Four groups are described: Episodic Future Thinking (EFT), Volitional Choice (VC), Episodic Future Thinking Plus Volitional Choice, and Monitoring Only. Their posted group sizes are 17, 21, 19, and 18 participants, respectively. The descriptions distinguish the active behavioral components: EFT messages focus on positive future events unrelated to alcohol, VC messages support structured if-then planning, and the combined group receives both. Monitoring Only is described as a control group receiving general psychoeducation. The registry record does not specify which people were masked or how masking was maintained.

The factorial label indicates the registry classification of the design, but details of the factorial structure, including the factors and their levels, are not reported in the registry record. The posted comparisons use EFT as the reference group for VC, the combined intervention, and Monitoring Only in the primary outcome results. Secondary alcohol-consumption comparisons are posted for VC and the combined intervention against EFT. The registry record does not report a comparison of Monitoring Only with EFT for that secondary outcome.

The stated study purpose was developmental: to obtain feedback for phone- and text-delivered programs for wellness and health behaviors. Alcohol use is listed as a condition, and Alcohol Consumption is the secondary outcome. The primary outcome instead concerns completion of an intervention phone call on Day 1. The record lists four outcome measures, but outcome-specific details for measures beyond the posted primary measure and the Alcohol Consumption entry are not reported in the registry record. A protocol-level statistical plan, eligibility details, and the rationale for the enrollment target are also not reported in the registry record.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Feasibility of the Intervention - Screening, measured over Day 1 of Intervention.

The primary endpoint is described as the feasibility of the intervention, specifically screening measured by the percent of participants who complete the intervention phone call. Its unit is participants, its parameter is a count of participants, and its timeframe is Day 1 of Intervention. The posted group results give the number completing the call in each arm: 17 in EFT, 21 in VC, 19 in the combined group, and 18 in Monitoring Only. These counts equal the respective group sizes reported in the registry record. The posted comparisons report proportions of 1.0 in both groups being compared and risk differences of 0.0.

This measure is useful for an early feasibility question because it records whether participants completed an initial study contact. It describes a concrete step required for participation in the intervention and can indicate whether the call was completed among those enrolled in each arm. It does not, by itself, describe engagement with every later message, adherence over the intervention period, participant satisfaction, or changes in alcohol consumption. Those are different questions and require their own outcome definitions and results.

The registry record does not report further operational detail about how completion was verified, what counted as a completed call, or how the percentage was calculated when a participant could not be reached. The posted counts support a description of the recorded Day 1 call outcome, but do not establish the broader acceptability or practicality of all phone and text components.

7. Results Posted in the Registry

• Volitional Choice (VC): 100.0% (21/21) versus 100.0% (17/17) on control; risk difference 0.0 percentage points (95% CI 0.0 to 0.0), risk ratio 1.00 (1.00–1.00); unadjusted two-proportion z-test p = n/a.
• Episodic Future Thinking Plus Volitional Choice: 100.0% (19/19) versus 100.0% (17/17) on control; risk difference 0.0 percentage points (95% CI 0.0 to 0.0), risk ratio 1.00 (1.00–1.00); unadjusted two-proportion z-test p = n/a.
• Monitoring Only: 100.0% (18/18) versus 100.0% (17/17) on control; risk difference 0.0 percentage points (95% CI 0.0 to 0.0), risk ratio 1.00 (1.00–1.00); unadjusted two-proportion z-test p = n/a.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Alcohol Consumption

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Volitional Choice (VC): mean 17.90 versus 22.10 on control; difference -4.20 (95% CI -17.89 to 9.49), standardized effect d = -0.21; z-test p = 0.548.
  • Episodic Future Thinking Plus Volitional Choice: mean 28.10 versus 22.10 on control; difference 6.00 (95% CI -19.70 to 31.70), standardized effect d = 0.15; z-test p = 0.647.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Volitional Choice (VC) and the control. The interval gives the range of effects that remain compatible with the data.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Episodic Future Thinking Plus Volitional Choice and the control. The interval gives the range of effects that remain compatible with the data.

The secondary outcome asks a different question from the primary feasibility measure. Completion of an initial intervention call describes whether an early study procedure was completed. Alcohol Consumption summarizes standard drinks per person during the intervention period. The primary result therefore cannot validate, explain, or replace the secondary outcome, and the secondary outcome does not change what the primary count measures.

Across the posted alcohol-consumption summaries, arm averages are not identical, but the two reported unadjusted contrasts against EFT have wide confidence intervals that include no difference and allow values in either direction. The pattern does not support a precise claim that either compared arm had a higher or lower mean than EFT. The Monitoring Only arm has a posted descriptive mean and standard deviation, but no corresponding secondary comparison with EFT is listed. The registry record does not report inferential results for that contrast or for a factorial interaction.

These secondary results carry less weight than a prespecified primary analysis would ordinarily carry. The registry record lists 4 outcome measures, identifies Alcohol Consumption as a secondary outcome, and lists 0 reported analyses. It does not report a multiplicity strategy, a prespecified hierarchy among secondary outcomes, or the complete analytic plan. When multiple outcomes or contrasts are considered, unadjusted p-values do not account for the increased opportunity to observe a result that appears notable by chance. General statistical explanation: multiplicity adjustment or a clear prespecified hierarchy can help control that interpretive problem, but neither is reported in the registry record.

The secondary estimates are recalculated from posted summary statistics and are unadjusted. They are informative as descriptive comparisons, but should not be treated as a complete confirmatory analysis. The large spread in some arm-level observations and the limited group sizes also constrain precision. Without reported analysis populations, missing-data handling, or a model for the factorial structure, the posted secondary pattern is best treated as preliminary rather than as a definitive account of differences among all four groups.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Alcohol Consumption

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is binary at the participant level: a participant either completed the intervention phone call or did not. The registry presents counts, group sizes, proportions, and risk differences. General statistical explanation: a proportion describes the share of participants with the event of interest, while a risk difference subtracts one group’s proportion from another group’s proportion. A risk difference of 0.0 means the reported proportions are equal. It does not establish that all aspects of the interventions are equivalent; it describes only the measured event and the groups compared.

What does a risk difference say?

For the primary outcome, each listed comparison is between an intervention arm and EFT. Both groups in each comparison have a reported proportion of 1.0, so the risk difference is 0.0. The comparison is therefore a summary of the observed completion proportions, rather than a model-based estimate of a broader intervention effect. Since no participant in these posted groups is recorded as not completing the call, the available primary-outcome results do not distinguish the groups on this measure. The record does not describe an alternative method for handling a missing or unobserved call outcome.

The secondary outcome is continuous: Alcohol Consumption is reported as standard drinks per person, with a mean and standard deviation for each arm. General statistical explanation: the mean is the arithmetic average, while the standard deviation describes the spread of individual values around that average. A mean difference compares the average in one arm with the average in the reference arm. A positive value indicates a higher reported mean in the comparison arm under the posted subtraction order; a negative value indicates a lower reported mean. The sign alone does not indicate a statistically persuasive difference.

How should the secondary comparisons be read?

The posted mean differences are recalculated unadjusted comparisons based on the arm-level summaries. The confidence intervals express uncertainty around those estimated differences under the calculation method. The reported unadjusted p-values quantify compatibility with a null hypothesis of no difference under the assumptions of that test; they do not measure the probability that the null hypothesis is true. These analyses do not account for covariates or multiplicity in the posted results. The registry record does not report the sponsor’s own inferential analysis for this endpoint.

The reported standard deviations differ across the arms, and the combined group has a particularly large standard deviation. General statistical explanation: over-dispersion, or greater variability than a simple model expects, can make an average less precise and can complicate analyses that rely on a common spread or a particular distributional shape. Unequal or large variability can widen uncertainty and can make a small group mean sensitive to individual observations. The posted comparisons use their reported summary statistics, but the registry record does not report diagnostic checks, transformations, robust methods, or a model addressing unequal variances. No specific distribution should therefore be assumed beyond the stated calculation approach.

The registry’s planning illustration uses a normal approximation, equal allocation between two arms, and a two-sided significance level of 0.05. It varies the effect to detect as a stated fraction of the observed effect and reports participants per arm for 80% power and 90% power. General statistical explanation: a planning calculation asks how large a future study might need to be under specified assumptions. It is not a measure of the probability that the current trial detected an effect, and it is not observed power. The illustration is explicitly based on the observed effect rather than the trial’s own design. The sample-size justification and assumptions used to set this trial’s enrollment target are not reported in the registry record.

The registry record identifies the study as factorial, but does not report a factorial analysis plan or estimated main effects and interaction effects. The posted comparisons should therefore be read as the specific arm-to-arm summaries described, not as a complete analysis of factorial components. The record lists 0 reported analyses. It does not report an analysis population definition, a missing-data method, an adjustment set, or a prespecified model. General statistical explanation: prespecified analysis choices help readers distinguish planned confirmatory comparisons from exploratory comparisons and can reduce ambiguity when several outcomes or contrasts are examined.

The registry marks no discrepancy between the posted results and its results information. The secondary comparisons are explicitly unadjusted recalculations from posted summary statistics, rather than sponsor-reported analyses. If a discrepancy were flagged, the sponsor’s own analysis would take precedence; no such discrepancy is flagged in this record. The primary counts and proportions are presented as registry results, with no reported inferential model or formal hypothesis test for the primary feasibility endpoint.

11. Confidence Intervals and Precision

Precision concerns how much uncertainty surrounds an estimate. A confidence interval gives a range of values compatible with the observed data under a specified statistical procedure and its assumptions. It is not a guarantee that the true value lies within the interval, and its width matters: a wider interval indicates less precision than a narrower one on the same scale.

For the primary outcome, each reported risk difference is 0.0, and the interval limits are 0.0 and 0.0. This reflects the posted result that all participants in each compared group completed the call, leaving no observed difference in these proportions. The registry record does not provide an alternative uncertainty interval for the primary outcome. A zero-width interval in these posted results should not be interpreted as proof that the groups are identical in the broader population or on other outcomes. It describes the recorded comparison and does not account for unreported sources of uncertainty, such as how participants were selected or how missing outcomes would be handled.

For alcohol consumption, the reported interval for VC versus EFT runs from -17.89 to 9.495, and the interval for the combined group versus EFT runs from -19.7 to 31.7. Both cover zero and include values on both sides of no difference. They are wide relative to the point estimates, indicating substantial uncertainty about the size and direction of the mean differences. The unadjusted p-values of 0.548 and 0.647 are consistent with the intervals not excluding zero under the posted calculations, but neither a p-value nor an interval establishes that there is no meaningful difference.

The arm-level standard deviations and group sizes are also relevant to precision. The relatively large variation in alcohol consumption, especially in the combined arm, means that the mean estimates are based on data with considerable spread. The registry record does not report confidence intervals for each arm mean, nor sponsor-reported model-based intervals. Precision should be judged from the interval estimates and the study context, not from the numerical point estimate alone.

12. Multiplicity, Missing Data and Analysis Populations

The registry record does not report a multiplicity plan. It lists 4 outcome measures, while Alcohol Consumption is identified as a secondary outcome and the Day 1 phone-call completion measure is the posted primary endpoint. The record does not report whether the outcomes were ordered in a hierarchy, whether any contrasts were designated confirmatory, or whether statistical significance thresholds were adjusted for multiple outcomes or comparisons. The posted alcohol-consumption p-values are unadjusted. They should therefore be interpreted as individual comparisons, not as family-wise error-controlled evidence across every outcome and contrast.

The record lists 0 reported analyses and does not provide a detailed analysis plan. The model used for the factorial design, any covariate adjustment, subgroup analyses, and the handling of repeated or correlated observations are not reported in the registry record. The record does not describe an interim analysis plan or stopping rule. These omissions do not establish that such procedures were or were not used; they mean that the information is not reported in the registry record.

Missing-data procedures are not reported in the registry record. The posted primary counts equal the listed arm sizes, but the record does not describe how missing call outcomes would have been treated, whether any participants withdrew, or whether all randomized participants were included in an analysis population. The analysis population, such as intention-to-treat or per-protocol, is not reported in the registry record. The record also does not report the amount or pattern of missing alcohol-consumption data, the method used to handle any missing responses, or whether the posted summaries include every randomized participant.

General statistical explanation: missingness can affect estimates if the likelihood of an outcome being observed is related to participant characteristics or outcomes. Analysis-population definitions and missing-data methods help readers understand which participants contribute to each estimate and what assumptions support the result. Without those details, the posted group summaries remain interpretable as registry results, but the robustness of the estimates to missingness cannot be assessed. The registry record does not report enough information to determine whether the secondary comparisons were planned before outcome data were examined.

13. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The posted safety figures show 0 serious adverse events among participants at risk in each group and 0 deaths in each group. The record also reports 0 participants affected by other adverse events in each group. The numbers at risk are 17 for EFT, 21 for VC, 19 for the combined intervention, and 18 for Monitoring Only.

These figures describe events recorded in the registry safety results; they do not demonstrate that the interventions are free of risk. With no reported events, the results cannot estimate the frequency or range of possible events with precision, and the registry record does not provide event terms for serious events. The absence of reported events should be read as a statement about the recorded observations and the reporting in the registry, not as proof that no participant experienced any symptom or problem outside the event categories captured. Details about how adverse events were solicited, monitored, classified, or attributed are not reported in the registry record.

14. What the Result Does, and Does Not, Mean

The primary result means that the posted registry data record completion of the Day 1 intervention phone call for every participant listed in each of the four arms. The reported proportions are 1.0 in each compared group, and the risk differences against EFT are 0.0. This is evidence about one early feasibility step within this study. It does not directly measure completion of the text-message intervention over time, continued study participation, or acceptability of the program as a whole.

The result does not establish that the behavioral approaches have the same effect on alcohol consumption. The secondary outcome is a separate measure, and its unadjusted comparisons have considerable uncertainty. Nor do the results show that any intervention increases or decreases drinking. The posted analyses do not support a firm conclusion about the direction or size of differences in alcohol consumption across the compared arms.

Enrollment was 75, and the reported arm sizes range from 17 to 21 participants. General statistical explanation: estimates from limited samples can be sensitive to individual observations and may remain uncertain even when the observed results look simple. That consideration is especially relevant for a variable outcome with substantial spread. The confidence intervals, not just the point estimates, show that the alcohol-consumption comparisons are compatible with a range of possible differences.

The trial is classified as randomized, double-masked, and factorial, but the registry record does not report how masking was implemented or how the factorial design was analyzed. It does not report a sponsor analysis, a prespecified analysis plan, or missing-data procedures. As a result, the posted summaries should not be generalized beyond the recorded outcomes and comparisons without further information. The findings describe this completed study’s registry results; they do not establish results in every rural population or for other phone- and text-delivered programs.

The study’s stated purpose was to gather feedback to help develop programs. The completion finding may inform that feasibility question, but the registry results alone do not establish what design changes were made or whether the approaches were retained for later evaluation. Such follow-up information is not reported in the registry record.

15. Why This Trial Matters Statistically

This trial illustrates why a feasibility endpoint and a behavioral outcome should be kept conceptually distinct. The primary measure is completion of an initial phone call, a practical process outcome. Alcohol consumption is a secondary behavioral outcome measured over the intervention period. The primary result can describe whether participants completed that first step, but it cannot answer whether drinking differed among groups. Separating these questions prevents a successful process measure from being mistaken for evidence about an outcome it was not designed to measure.

The results also demonstrate how confidence intervals add context to point estimates. The posted alcohol-consumption differences are modest in relation to the uncertainty reflected by their intervals, which include no difference and values in both directions. A single estimate or an unadjusted p-value would not convey the full range of uncertainty. The wide variation in the group summaries further underscores the importance of reporting spread and not only averages.

There is also a useful design lesson in the registry’s factorial classification. A factorial label can imply questions about individual intervention components and their combination, but such questions require analyses that correspond to the design. The registry record does not report those analyses, so the available arm-to-arm comparisons cannot be read as a complete evaluation of component effects or interactions. Clear reporting of design structure and analysis choices is important for interpreting such trials.

Finally, planning calculations should be separated from conclusions about the completed study. The posted sample-size illustration uses the observed effect and specified assumptions to show planning scenarios for a future study. It is not observed power and does not establish the original design rationale. Keeping that distinction explicit helps readers avoid treating a post hoc planning illustration as a property of the trial’s evidence.

16. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

Several limitations specific to this trial affect how broadly the posted results can be interpreted. The registry reports enrollment of 75 participants across four arms. The record does not provide participant demographics, detailed eligibility criteria, or information on how participants were recruited, beyond describing adults seen in primary care settings who lived in rurally designated areas. It is therefore not possible to assess how representative the enrolled participants were of rural populations more generally.

The primary endpoint is narrow: completion of an intervention phone call on Day 1. The registry record does not report the definition of completion, how call attempts were handled, or whether subsequent phone or text engagement was measured in the posted results. The endpoint supports a limited feasibility description and does not capture all practical challenges of delivering the intervention.

The posted alcohol-consumption comparisons are unadjusted recalculations from summary statistics, and no sponsor-reported analyses are listed. The record does not report the statistical plan, the analysis population, covariate adjustment, missing-data methods, or a model of the factorial structure. No Monitoring Only comparison is posted for alcohol consumption. The effects of these unreported analytic choices cannot be evaluated from the registry summaries.

The secondary outcome has substantial variability in at least one arm, and its comparison intervals are wide. Consequently, the estimates do not narrowly determine the size or direction of group differences. The registry record also does not report detailed event-collection methods for safety outcomes. Zero recorded adverse events should not be interpreted as a comprehensive estimate of safety beyond the observations and reporting captured.

Finally, the record does not report a sample-size justification for the original enrollment target, a multiplicity plan, or an interim analysis plan. These details are relevant to judging the intended scope of inference and the status of secondary comparisons. Their absence from the registry record limits evaluation; it does not show that the procedures were absent from the study itself.

17. Related Tutorials

18. Related Statistical Calculators

19. Sources

• ClinicalTrials.gov: Behavioral Economic Treatment to Enhance Rural (BETTER) Living — NCT05235971.
• Registry record last updated 2025-03-26; status last verified 2025-03.
• Results first posted 2024-07-10.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

20. Record Summary

NCT05235971, Behavioral Economic Treatment to Enhance Rural (BETTER) Living, is listed as a completed randomized, double-masked factorial study sponsored by the University of Michigan. The registry reports enrollment of 75 and a phase of NA. The study start date is 2022-05-17, and primary completion is dated 2023-05-08. The described arms are EFT, VC, their combination, and Monitoring Only.

The posted primary outcome concerns completion of an intervention phone call on Day 1. The reported count in each arm equals that arm’s listed group size, and the comparisons against EFT report risk differences of 0.0. Alcohol Consumption is listed as a secondary outcome, measured as standard drinks per person during the 2 weeks (14-days) of the intervention period. The two posted unadjusted comparisons against EFT have wide confidence intervals that include zero. The registry record lists 0 reported analyses and does not report a detailed statistical plan, missing-data handling, or a multiplicity strategy.