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Engaging Rural Men With Mobile Technologies for Weight Loss

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ClinicalTrials.gov Identifier: NCT03329079
Recruitment Status : Recruiting
First Posted : November 1, 2017
Last Update Posted : September 5, 2018
Sponsor:
Collaborator:
Northeast Nebraska Public Health Department
Information provided by (Responsible Party):
Christine Eisenhauer, University of Nebraska

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 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.

Condition or disease Intervention/treatment Phase
Weight Loss Behavioral: Mobile Technology Plus Behavioral: Mobile Technology Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: The research nurse 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.
Primary Purpose: Prevention
Official Title: Engaging Rural Men With Mobile Technologies for Weight Loss: A Randomized Controlled Trial.
Actual Study Start Date : June 6, 2018
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: 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.
Other Name: MT+

Active Comparator: Mobile Technology (MT)
Comparison group will receive the basic version of the mobile phone app only.
Behavioral: Mobile Technology
The comparison group MT will receive the basic-version mobile phone app only to self monitor eating, activity, and weight.
Other Name: MT




Primary Outcome Measures :
  1. Change in Weight [ Time Frame: Change from baseline weight at 6 months ]
    Weight in kilograms measured per Tanita digital scale (TBF-215 Tanita Corporation of America)


Secondary Outcome Measures :
  1. Change in Fruit and Vegetable Intake [ Time Frame: Change from baseline fruit and vegetable intake at 6 months ]
    daily fruit and vegetable servings (Brief Risk Factor Surveillance Survey written questionnaire- Fruit and vegetable dietary intake module- 6 item (scale range= 1 per day (desired outcome) to 9 (refused)

  2. Change in Beverage Intake Quality [ Time Frame: Change in baseline beverage intake quality at 6 months ]
    sugar-sweetened total beverage energy intake (Brief Questionnaire to Assess Beverage Intake- 15 item: Scale 0= never or less than 1 time per week (desired outcome) to 6= 3 or more times per day

  3. Change in Overall Diet Quality [ Time Frame: Change in baseline overall diet quality at 6 months ]
    dietary intake quality (Lose-It app automated report of dietary quality (fruits, vegetable, whole grain, milk, meat/protein servings as outlined by the 2005 Dietary Guidelines for Americans) as analyzed from self-reported dietary log input)

  4. Change in physical activity [ Time Frame: Change in baseline overall physical activity at 6 months ]
    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)



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Ages Eligible for Study:   40 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Participant eligibility is based upon self-representation of gender identity.
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03329079


Contacts
Contact: Christine Eisenhauer, PhD 402-844-7897 ceisenhauer@unmc.edu
Contact: Carol Pullen, EdD 402-559-6548 chpullen@unmc.edu

Locations
United States, Nebraska
University of Nebraska Medical Center Recruiting
Norfolk, Nebraska, United States, 68701
Contact: Christine Eisenhauer, PhD    402-844-7897    ceisenhauer@unmc.edu   
Contact: Carol Pullen, EdD    402-559-6548    chpullen@unmc.edu   
Sponsors and Collaborators
University of Nebraska
Northeast Nebraska Public Health Department
Investigators
Study Director: Ann Berger, PhD University of Nebraska

Publications:
Responsible Party: Christine Eisenhauer, Assistant Professor, University of Nebraska
ClinicalTrials.gov Identifier: NCT03329079     History of Changes
Other Study ID Numbers: 594-17-EP
First Posted: November 1, 2017    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undecided: It is not yet known if there will be a plan to make IPD available.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Christine Eisenhauer, University of Nebraska:
rural
men
community-based participatory research
weight loss
mobile applications
text messaging

Additional relevant MeSH terms:
Body Weight
Weight Loss
Signs and Symptoms
Body Weight Changes