Engaging Rural Men With Mobile Technologies for Weight Loss

NCT03329079 | Completed Results DMC

• 1 other identifier: 0594-17-EP
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Weight Loss

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Mean Change in Weight by Randomized Group

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

  Observed means from baseline weight and at 6 months

Secondary Outcomes (3)

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

  Observed means from baseline fruit and vegetable intake at 6 months

• Point Estimate and Variability of Outcome Measure for Beverage Intake Quality

  Observed means from baseline beverage intake and at 6 months

• Point Estimate and Variability of Outcome Measure for Physical Activity

  Observed means from baseline overall physical activity and at 6 months

Study Arms (2)

Mobile Technology Plus (MT+)

EXPERIMENTAL

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

Mobile Technology (MT)

ACTIVE COMPARATOR

Comparison group will receive the basic version of the mobile phone app only.

Behavioral: Mobile Technology

Interventions

Mobile Technology Plus BEHAVIORAL

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+

Mobile Technology Plus (MT+)

Mobile Technology BEHAVIORAL

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

Also known as: MT

Mobile Technology (MT)

Eligibility Criteria

• Age: 40 Years - 69 Years
• Gender Eligibility Details: Participant eligibility is based upon self-representation of gender identity.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead
• Northeast Nebraska Public Health Department: collaborator

Study Sites (1)

University of Nebraska Medical Center

Norfolk, Nebraska, 68701, United States

Location

Related Publications (6)

• Eisenhauer CM, Hageman PA, Rowland S, Becker BJ, Barnason SA, Pullen CH. Acceptability of mHealth Technology for Self-Monitoring Eating and Activity among Rural Men. Public Health Nurs. 2017 Mar;34(2):138-146. doi: 10.1111/phn.12297. Epub 2016 Oct 18.

  PMID: 27757986 BACKGROUND

• Hageman PA, Pullen CH, Yoerger M. Physical Function and Health-Related Quality of Life in Overweight and Obese Rural Women Who Meet Physical Activity Recommendations. J Aging Phys Act. 2018 Jul 1;26(3):438-444. doi: 10.1123/japa.2017-0117. Epub 2018 Jun 13.

  PMID: 28952857 BACKGROUND

• Hageman PA, Pullen CH, Hertzog M, Pozehl B, Eisenhauer C, Boeckner LS. Web-Based Interventions Alone or Supplemented with Peer-Led Support or Professional Email Counseling for Weight Loss and Weight Maintenance in Women from Rural Communities: Results of a Clinical Trial. J Obes. 2017;2017:1602627. doi: 10.1155/2017/1602627. Epub 2017 Apr 5.

  PMID: 28480078 BACKGROUND

• Eisenhauer CM, Brito FA, Yoder AM, Kupzyk KA, Pullen CH, Salinas KE, Miller J, Hageman PA. Mobile technology intervention for weight loss in rural men: protocol for a pilot pragmatic randomised controlled trial. BMJ Open. 2020 Apr 14;10(4):e035089. doi: 10.1136/bmjopen-2019-035089.

  PMID: 32295776 BACKGROUND

• Eisenhauer CM, Brito F, Kupzyk K, Yoder A, Almeida F, Beller RJ, Miller J, Hageman PA. Mobile health assisted self-monitoring is acceptable for supporting weight loss in rural men: a pragmatic randomized controlled feasibility trial. BMC Public Health. 2021 Aug 18;21(1):1568. doi: 10.1186/s12889-021-11618-7.

  PMID: 34407782 BACKGROUND

• Metzendorf MI, Wieland LS, Richter B. Mobile health (m-health) smartphone interventions for adolescents and adults with overweight or obesity. Cochrane Database Syst Rev. 2024 Feb 20;2(2):CD013591. doi: 10.1002/14651858.CD013591.pub2.

  PMID: 38375882 DERIVED

MeSH Terms

Conditions

Weight Loss; Multiple Endocrine Neoplasia Type 1

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Results Point of Contact

• Title: Kevin Kupzyk
• Organization: University of Nebraska Medical Center

kkupzyk@unmc.edu

402-552-7262

Study Officials

• Ann M Berger, PhD

  University of Nebraska

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2017
• First Posted: November 1, 2017
• Study Start: June 6, 2018
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: October 4, 2023
• Results First Posted: October 4, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)