Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Weight Loss
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Masking Description: The research nurse will know which group assignment the subject has been given as is required for him to download the appropriate app and provide training on the technology to the subject.Primary Purpose: Prevention

Participation Requirements

Age
Between 40 years and 69 years
Gender
Only males

Description

Obesity is a major public health problem that disproportionately affects rural men and promotes the development of chronic conditions such as diabetes, cardiovascular disease, arthritis, and cancer. This study proposes to evaluate a mobile self-monitoring application (app) with Wi-Fi scale and text ...

Obesity is a major public health problem that disproportionately affects rural men and promotes the development of chronic conditions such as diabetes, cardiovascular disease, arthritis, and cancer. This study proposes to evaluate a mobile self-monitoring application (app) with Wi-Fi scale and text messaging intervention (MT+: mobile technology plus) for achieving weight loss in overweight and obese rural men. This proposal aligns with 1) Healthy People 2020's aim to eliminate health disparities by increasing physical activity and reducing obesity in adults; 2) the NIH's strategic plan to prioritize obesity reduction research among underserved rural populations; and, 3) the NINR's strategic focus on technology to promote health. Sixty nine percent of rural men in Nebraska are overweight or obese with increasing prevalence during midlife 40-59 (40%) and older (36%). Rural men are more likely to smoke, be obese, be physically inactive, and have shorter lifespans (2 years) than urban men. Rural men are also more likely to be uninsured/underinsured, less likely to engage in preventive health services, and report overall poorer health than urban men. Despite the burden of obesity, no self-monitoring mobile technology interventions targeting weight loss in rural, U.S. males exist, though the investigators preliminary study demonstrated rural men will use mobile technology for eating and activity self-monitoring. Studies show self-monitoring as one of the most effective behavior-change techniques for weight loss. MT+ provides an accessible means of real-time self-monitoring support for targeting lifestyle behaviors that lead to weight loss. The investigators propose a pragmatic, randomized controlled trial (RCT) to examine the feasibility, acceptability, and preliminary efficacy of a MT+ intervention for weight loss in overweight and obese men in a practical, real-life rural environment. This 6-month pilot RCT includes a 3-month intervention with 6-month post-baseline follow-up. The intervention group (n=40) will receive a 3-month MT+ intervention using a commercially available, premium-version mobile phone app with social comparison group, behavior change text messaging, and daily self-weighing via Wi-Fi scale. The comparison group (n=40) will receive the basic-version mobile phone app only (MT). Primary efficacy outcome will be loss of body weight (kg & % body weight) at 3 and 6 months. Secondary outcomes will be improved diet and increased physical activity (PA). A multi-method formative evaluation of the intervention (student outreach, community advisory board (CAB), community capacity surveys, focus group, community dissemination) will occur across the study. Primary feasibility outcomes will include recruitment/retention rates and community resource development for program sustainment. The multi-modal feedback will help 1) facilitate recruitment of a hard-to-reach population, and 2) inform intervention feasibility and acceptability. These local insights may foster minimized attrition and improve future study outcomes. The specific aims of this study are: Aim #1: Determine the feasibility and acceptability of a MT+ intervention for achieving weight loss in rural overweight and obese men. The aim will specifically address groups by the 1) participation rates including number of men recruited and randomized over a 6 month period. 2) retention rates, 3) feasibility, usability, satisfaction ratings, 4) adherence record of logging by men in the intervention group, and 5) evaluative focus group feedback. Aim #2: Determine preliminary efficacy of a MT+ intervention to a comparison group receiving only a basic self-monitoring app (MT) in achieving 1) weight loss (primary), and 2) improved dietary and PA behavior (secondary) at 3 months post-baseline and follow-up at 6 months post-baseline in rural men. Aim #3: Determine quantitative and qualitative indicators of community capacity (resource mobilization, learning opportunities-skills development, partnership linkages, participatory decision-making, leadership) to support a relevant weight loss intervention for rural men. Through a collaborative process guided by Community-Engaged Research (CEnR) approaches with a community-academic partnership involving UNMC students, community leaders, the investigators plan to create and disseminate local knowledge about obesity in rural men. Specifically, the investigators plan to 1) document the feasibility, acceptability, and preliminary efficacy of a weight loss intervention among rural men, a current gap in the NIH health disparities portfolio, 2) engage rural communities through student-informed outreach approaches and CAB partnership linkages to improve the efficacy of weight loss interventions for rural men, and 3) strengthen the research environment of the University of Nebraska Medical Center (UNMC) institution through providing opportunities for undergraduate and graduate students to conduct CEnR.

Tracking Information

NCT #
NCT03329079
Collaborators
Northeast Nebraska Public Health Department
Investigators
Study Director: Ann Berger, PhD University of Nebraska