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N/A N=80 Randomized Prevention

Engaging Rural Men With Mobile Technologies for Weight Loss

Weight Loss

Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcome: Primary: Mean Change in Weight by Randomized Group — -7.03; -4.14 kilograms

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Mobile Technology Plus (Behavioral); Mobile Technology (Behavioral)
Age
Adult, Older Adult · 40+ yrs
Sex
Male
Sponsor
University of Nebraska
Primary completion
Jun 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Mean Change in Weight by Randomized Group
-7.03; -4.14
SECONDARY
Point Estimate and Variability of Outcome Measure for Fruit and Vegetable Intake
3.16; 3.09
SECONDARY
Point Estimate and Variability of Outcome Measure for Beverage Intake Quality
4.34; 10.58
SECONDARY
Point Estimate and Variability of Outcome Measure for Physical Activity
6874.64; 5359.50

Summary

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03329079). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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