Engaging Rural Men With Mobile Technologies for Weight Loss
| Status: | Recruiting |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 40 - 69 |
| Updated: | 9/7/2018 |
| Start Date: | June 6, 2018 |
| End Date: | October 2020 |
| Contact: | Christine Eisenhauer, PhD |
| Email: | ceisenhauer@unmc.edu |
| Phone: | 402-844-7897 |
Engaging Rural Men With Mobile Technologies for Weight Loss: A Randomized Controlled Trial.
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 3 and 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.
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 3 and 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.
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.
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.
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
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