An interventional study of Mobile Technology Plus and Mobile Technology in Weight Loss, sponsored by University of Nebraska. Completed at 1 site in United States. Open to male participants aged 40 Years to 69 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-04.
Sponsored by University of Nebraska · Not applicable, Interventional, and Prevention
Among 995 studies in Weight Loss with a site in United States — 114 open to participants now, 169 under way, 6 of them phase 3. Weight Loss · United States.
Among the 995 studies in Weight Loss with a site in United States, this one is the 422nd largest by enrollment of the 912 interventional ones that give a count, is one of 59 that started in 2018, is one of 714 with no phase, and was the 562nd registered.
1,815 studies on the registry are indexed under Weight Loss; 294 are open to participants now.
Browse Weight Loss studies →114 of the 995 studies in Weight Loss with a site in United States are open now. Recruiting first, the newest first:
Regeneron Pharmaceuticals · Sites in United States
Icahn School of Medicine at Mount Sinai · Sites in United States
Morehouse School of Medicine · Sites in United States
Duke University · Sites in United States
Viking Therapeutics, Inc. · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 196 Weight Loss studies recruiting now, 71 (36%) set no upper age limit and 108 (55%) stop at 75 or younger; 21 take children under 18; 58 take healthy volunteers.
This study: 40 Years to 69 Years · male · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
995 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 48 · Phase 2 106 · Phase 3 38 · Phase 4 33
First in 1996; this study’s year is marked. 59 started in 2018.
This study's enrollment of 80 is close to the median of 80 across 1,561 interventional studies indexed under Weight Loss.
Median enrollment 72 across the 912 interventional studies, 99 across the 76 observational. Of the 769 that completed or were terminated, 230 (30%) have results posted.
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116 of 995 have an industry lead sponsor. The 10 most frequent:
University of Nebraska is the lead sponsor of 496 studies on the registry; 67 are open to participants now.
Of its 83 completed or terminated interventional studies of FDA-regulated products, 53 (64%) have results posted.
University of Nebraska has 5 studies filed under Weight Loss — fewer than ten, so there is no comparison to draw.
57 of the studies in Weight Loss with a site in United States that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07298915Phase 3University of VirginiaThe Effect of Exercise and Tirzepatide on Weight and Health Outcomes (EXER-MED) | 2026-12 |
| NCT07223242Phase 3University of Texas Southwestern Medical CenterTailored Exercise Training Study Among Adults With HFpEF | 2026-12-30 |
| NCT07104383Phase 3Viking Therapeutics, Inc.VK2735 for Weight Management Type 2 Diabetes Phase 3 (VANQUISH 2) | 2027-07-01 |
| NCT07104500Phase 3Viking Therapeutics, Inc.VK2735 for Weight Management Phase 3 | 2027-07-01 |
| NCT07560579Million Marker Wellness, Inc.Weight Loss and Endocrine Disrupting Chemicals (EDCs): Lifestyle Interventions to Lose Weight and Reduce EDC Exposure in Individuals With Overweight/Obesity | 2026-11 |
Among the 995 studies in Weight Loss with a site in United States, from their registry updates:
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Mobile Technology Plus
Comparison group will receive the basic version of the mobile phone app only.
Behavioral: Mobile Technology
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.
Also known as: MT+
The comparison group MT will receive the basic-version mobile phone app only to self monitor eating, activity, and weight.
Also known as: MT
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
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
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
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
| Milestone | Mobile Technology Plus (MT+) | Mobile Technology (MT) |
|---|---|---|
| Started | 40 | 40 |
| Completed | 36 | 38 |
| Not completed | 4 | 2 |
Weight in kilograms (as measured on a Tanita brand digital scale, TBF-215 Tanita Corporation of America)
| kilograms | Mobile Technology Plus (MT+) | Mobile Technology (MT) |
|---|---|---|
| Mean Change in Weight by Randomized Group | -7.03 ± 2.9 | -4.14 ± 5.85 |
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)
| servings per day | Mobile Technology Plus (MT+) | Mobile Technology (MT) |
|---|---|---|
| Point Estimate and Variability of Outcome Measure for Fruit and Vegetable Intake | 3.16 ± 1.67 | 3.09 ± 1.54 |
sugar-sweetened total beverage energy intake (Sugar Sweetened beverage intake questionnaire (BEV-Q15) Reported total number of fluid ounces consumed per 24 hour period)
| fluid ounces per day | Mobile Technology Plus (MT+) | Mobile Technology (MT) |
|---|---|---|
| Point Estimate and Variability of Outcome Measure for Beverage Intake Quality | 4.34 ± 6.44 | 10.58 ± 17.01 |
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)
| Activity steps as measured by phone app | Mobile Technology Plus (MT+) | Mobile Technology (MT) |
|---|---|---|
| Point Estimate and Variability of Outcome Measure for Physical Activity | 6874.64 ± 4650.58 | 5359.50 ± 2995.44 |
Collected over 1 year, 5 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Mobile Technology Plus (MT+) | 0/40 (0%) | 0/40 (0%) | 0/40 (0%) |
| Mobile Technology (MT) | 0/40 (0%) | 0/40 (0%) | 0/40 (0%) |
| Age, Continuous(years) | Mobile Technology Plus (MT+) | Mobile Technology (MT) | Total |
|---|---|---|---|
| Mean | 54.06 ± 8.15 | 54.35 ± 9.10 | 54.20 ± 8.59 |
| Sex: Female, Male(Participants) | Mobile Technology Plus (MT+) | Mobile Technology (MT) | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 40 | 40 | 80 |
| Ethnicity (NIH/OMB)(Participants) | Mobile Technology Plus (MT+) | Mobile Technology (MT) | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 39 | 39 | 78 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Race (NIH/OMB)(Participants) | Mobile Technology Plus (MT+) | Mobile Technology (MT) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 40 | 38 | 78 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Mobile Technology Plus (MT+) | Mobile Technology (MT) | Total |
|---|---|---|---|
| United States | 40 | 40 | 80 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Summary results will be shared with all identifiers removed at the completion of the study after all analyses have been finalized.
Ran from Jun 2018 to primary completion in Jun 2022, 48 months.
Results were first posted in Oct 2023, 1 year 3 months after primary completion.
Of 670 non-industry interventional studies with no phase under Weight Loss, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 45. This study's 48 months is above that.
Counting every sponsor, half of 729 studies reached it within 24 months; a quarter within 11 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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