Clinical trial · Interventional
Engaging Rural Men With Mobile Technologies for Weight Loss
Engaging Rural Men With Mobile Technologies for Weight Loss: A Randomized Controlled Trial.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Overweight and obese men in rural Northeast Nebraska are an unrepresented, at-risk group exhibiting rising rates of cardiovascular disease, poor access to preventive care, and a rural milieu that contributes to their sedentary physical activity and unhealthy diet. This study proposes to use a pragmatic randomized controlled trial and community engaged research approaches to 1) determine the feasibility and acceptability of a commercially available, smart phone self-monitoring app (premium-version) plus text-based coaching and daily weighing via Wi-Fi scale intervention for achieving weight loss, 2) determine preliminary efficacy of this intervention group to a comparison group receiving only a self-monitoring app (basic-version) in achieving the outcomes of weight loss (kilogram) and improved dietary and physical activity behaviors (secondary) at 6 months post-baseline, and 3) determine quantitative and qualitative indicators of community capacity to support a contextually relevant weight loss intervention. Eighty men (ages 40-69) with body mass index of 28 or higher, randomly assigned (1:1 ratio) to intervention group or comparison group. Men will complete baseline assessments (weight, % body fat, body mass index height, blood pressure, health history, dietary intake, physical activity frequency/intensity) and receive orientation to the mobile technologies (app features, text messaging, Wi-Fi scale). Men will track their dietary intake, physical activity, and weight on the app for 12 weeks. After the 3-month intervention, post-measure assessments (weight, % body fat, BMI, dietary intake, PA frequency/intensity, technology usability surveys) will be collected at 3 and 6 months post-baseline. At 6 months post-baseline, two groups (n=8 each) of intervention completers will be purposively selected to share their perceptions of the intervention efficacy in an evaluative focus group. A community advisory board comprising local leaders within the men's social network, together with investigators and rural student nurses will guide community outreach efforts for study recruitment, implementation and evaluation. Study findings will be evaluated with the community to inform local dissemination, future intervention revision, and determination of community capacity for support of a larger clinical trial.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Weight Loss | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mobile Technology | Behavioral | — | UNRESOLVED |
| Mobile Technology Plus | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Mobile Technology Plus (MT+)
- description
- Experimental arm will receive a 3-month MT+ intervention using the premium mobile phone app version with social comparison group, behavior change text messaging, and daily self-weighing via Wi-Fi scale.
- interventionNames
- Behavioral: Mobile Technology Plus
- type
- ACTIVE_COMPARATOR
- label
- Mobile Technology (MT)
- description
- Comparison group will receive the basic version of the mobile phone app only.
- interventionNames
- Behavioral: Mobile Technology
Primary outcomes (1)
- measure
- Mean Change in Weight by Randomized Group
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 69 Years
Show eligibility criteria text
Inclusion Criteria: * Man age 40-69 * Reside in Northeast Nebraska * BMI of 28 (kg/m2) or higher (BMI greater than 50 with clinician clearance, maximum weight 396 pounds) * Smart phone owner with enabled text messaging * Have an email account * Answer "no" to all questions on the PAR-Q 17 health history assessment or are willing to get physician evaluation prior to enrolling * Willing to share self-monitoring logs of eating, activity, and weight with investigative team. Exclusion Criteria: * Have recently lost 5% or more of body weight * Are currently taking medications that cause or are influenced by weight loss * Have used weight loss app in the past to lose weight * Family member from same household is enrolled in this study * Type I diabetes or Type II diabetes with insulin dependence
References
Publications (6)
- BACKGROUNDEisenhauer CM, Hageman PA, Rowland S, Becker BJ, Barnason SA, Pullen CH. Acceptability of mHealth Technology for Self-Monitoring Eating and Activity among Rural Men. Public Health Nurs. 2017 Mar;34(2):138-146. doi: 10.1111/phn.12297. Epub 2016 Oct 18. PMID 27757986
- BACKGROUNDHageman PA, Pullen CH, Yoerger M. Physical Function and Health-Related Quality of Life in Overweight and Obese Rural Women Who Meet Physical Activity Recommendations. J Aging Phys Act. 2018 Jul 1;26(3):438-444. doi: 10.1123/japa.2017-0117. Epub 2018 Jun 13. PMID 28952857
- BACKGROUNDHageman PA, Pullen CH, Hertzog M, Pozehl B, Eisenhauer C, Boeckner LS. Web-Based Interventions Alone or Supplemented with Peer-Led Support or Professional Email Counseling for Weight Loss and Weight Maintenance in Women from Rural Communities: Results of a Clinical Trial. J Obes. 2017;2017:1602627. doi: 10.1155/2017/1602627. Epub 2017 Apr 5. PMID 28480078
- BACKGROUNDEisenhauer CM, Brito FA, Yoder AM, Kupzyk KA, Pullen CH, Salinas KE, Miller J, Hageman PA. Mobile technology intervention for weight loss in rural men: protocol for a pilot pragmatic randomised controlled trial. BMJ Open. 2020 Apr 14;10(4):e035089. doi: 10.1136/bmjopen-2019-035089. PMID 32295776
- BACKGROUNDEisenhauer CM, Brito F, Kupzyk K, Yoder A, Almeida F, Beller RJ, Miller J, Hageman PA. Mobile health assisted self-monitoring is acceptable for supporting weight loss in rural men: a pragmatic randomized controlled feasibility trial. BMC Public Health. 2021 Aug 18;21(1):1568. doi: 10.1186/s12889-021-11618-7. PMID 34407782
- DERIVEDMetzendorf MI, Wieland LS, Richter B. Mobile health (m-health) smartphone interventions for adolescents and adults with overweight or obesity. Cochrane Database Syst Rev. 2024 Feb 20;2(2):CD013591. doi: 10.1002/14651858.CD013591.pub2. PMID 38375882