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Engaging Rural Men With Mobile Technologies for Weight Loss

Engaging Rural Men With Mobile Technologies for Weight Loss: A Randomized Controlled Trial.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03329079
Enrollment
80
Registered
2017-11-01
Start date
2018-06-06
Completion date
2022-06-30
Last updated
2023-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Weight Loss

Keywords

rural, men, community-based participatory research, weight loss, mobile applications, text messaging

Brief 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.

Interventions

BEHAVIORALMobile Technology Plus

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.

BEHAVIORALMobile Technology

The comparison group MT will receive the basic-version mobile phone app only to self monitor eating, activity, and weight.

Sponsors

Northeast Nebraska Public Health Department
CollaboratorOTHER_GOV
University of Nebraska
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Masking description

The assessor 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.

Eligibility

Sex/Gender
MALE
Age
40 Years to 69 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Mean Change in Weight by Randomized GroupObserved means from baseline weight and at 6 monthsWeight in kilograms (as measured on a Tanita brand digital scale, TBF-215 Tanita Corporation of America)

Secondary

MeasureTime frameDescription
Point Estimate and Variability of Outcome Measure for Fruit and Vegetable IntakeObserved means from baseline fruit and vegetable intake at 6 monthsdaily fruit and vegetable servings (Brief Risk Factor Surveillance Survey written questionnaire- Fruit and vegetable dietary intake module (Reported total number of fruit and vegetable serving sizes per 24 hour period)
Point Estimate and Variability of Outcome Measure for Beverage Intake QualityObserved means from baseline beverage intake and at 6 monthssugar-sweetened total beverage energy intake (Sugar Sweetened beverage intake questionnaire (BEV-Q15) Reported total number of fluid ounces consumed per 24 hour period)
Point Estimate and Variability of Outcome Measure for Physical ActivityObserved means from baseline overall physical activity and at 6 monthstotal steps taken in 24 hour period (Automated app report of total steps measured via gyroscope on smart phone- total step count range 0-10,000 steps (higher step value represents desired outcome of 10,000 steps per day)

Countries

United States

Participant flow

Participants by arm

ArmCount
Mobile Technology Plus (MT+)
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. Mobile Technology Plus: 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.
40
Mobile Technology (MT)
Comparison group will receive the basic version of the mobile phone app only. Mobile Technology: The comparison group MT will receive the basic-version mobile phone app only to self monitor eating, activity, and weight.
40
Total80

Baseline characteristics

CharacteristicMobile Technology (MT)Mobile Technology Plus (MT+)Total
Age, Continuous54.35 years
STANDARD_DEVIATION 9.1
54.06 years
STANDARD_DEVIATION 8.15
54.20 years
STANDARD_DEVIATION 8.59
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
39 Participants39 Participants78 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants1 Participants2 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Black or African American
1 Participants0 Participants1 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
38 Participants40 Participants78 Participants
Region of Enrollment
United States
40 participants40 participants80 participants
Sex: Female, Male
Female
0 Participants0 Participants0 Participants
Sex: Female, Male
Male
40 Participants40 Participants80 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 400 / 40
other
Total, other adverse events
0 / 400 / 40
serious
Total, serious adverse events
0 / 400 / 40

Outcome results

Primary

Mean Change in Weight by Randomized Group

Weight in kilograms (as measured on a Tanita brand digital scale, TBF-215 Tanita Corporation of America)

Time frame: Observed means from baseline weight and at 6 months

ArmMeasureValue (MEAN)Dispersion
Mobile Technology Plus (MT+)Mean Change in Weight by Randomized Group-7.03 kilogramsStandard Deviation 2.9
Mobile Technology (MT)Mean Change in Weight by Randomized Group-4.14 kilogramsStandard Deviation 5.85
Secondary

Point Estimate and Variability of Outcome Measure for Beverage Intake Quality

sugar-sweetened total beverage energy intake (Sugar Sweetened beverage intake questionnaire (BEV-Q15) Reported total number of fluid ounces consumed per 24 hour period)

Time frame: Observed means from baseline beverage intake and at 6 months

ArmMeasureValue (MEAN)Dispersion
Mobile Technology Plus (MT+)Point Estimate and Variability of Outcome Measure for Beverage Intake Quality4.34 fluid ounces per dayStandard Deviation 6.44
Mobile Technology (MT)Point Estimate and Variability of Outcome Measure for Beverage Intake Quality10.58 fluid ounces per dayStandard Deviation 17.01
Secondary

Point Estimate and Variability of Outcome Measure for Fruit and Vegetable Intake

daily fruit and vegetable servings (Brief Risk Factor Surveillance Survey written questionnaire- Fruit and vegetable dietary intake module (Reported total number of fruit and vegetable serving sizes per 24 hour period)

Time frame: Observed means from baseline fruit and vegetable intake at 6 months

ArmMeasureValue (MEAN)Dispersion
Mobile Technology Plus (MT+)Point Estimate and Variability of Outcome Measure for Fruit and Vegetable Intake3.16 servings per dayStandard Deviation 1.67
Mobile Technology (MT)Point Estimate and Variability of Outcome Measure for Fruit and Vegetable Intake3.09 servings per dayStandard Deviation 1.54
Secondary

Point Estimate and Variability of Outcome Measure for Physical Activity

total steps taken in 24 hour period (Automated app report of total steps measured via gyroscope on smart phone- total step count range 0-10,000 steps (higher step value represents desired outcome of 10,000 steps per day)

Time frame: Observed means from baseline overall physical activity and at 6 months

ArmMeasureValue (MEAN)Dispersion
Mobile Technology Plus (MT+)Point Estimate and Variability of Outcome Measure for Physical Activity6874.64 Activity steps as measured by phone appStandard Deviation 4650.58
Mobile Technology (MT)Point Estimate and Variability of Outcome Measure for Physical Activity5359.50 Activity steps as measured by phone appStandard Deviation 2995.44

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026