Engaging Rural Men With Mobile Technologies for Weight Loss
Condition: Weight Loss
MeSH terms: Body Weight; Weight Loss
Study type: Interventional

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.
    

Detailed 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 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 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.
    

Intervention name(s): Mobile Technology Plus; Mobile Technology
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention group MT+ will receive the premium-version mobile phone app with social comparison group, behavior change text messaging, and daily self-weighing via Wi-Fi scale.; The comparison group MT will receive the basic-version mobile phone app only to self monitor eating, activity, and weight.
Other intervention name(s): MT+; MT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: rural; men; community-based participatory research; weight loss; mobile applications; text messaging