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The mFIT Study (Motivating Families With Interactive Technology) (mFIT)

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ClinicalTrials.gov Identifier: NCT02361151
Recruitment Status : Completed
First Posted : February 11, 2015
Last Update Posted : December 9, 2015
Sponsor:
Information provided by (Responsible Party):
University of South Carolina

Brief Summary:
The high rates of childhood obesity in the US demand innovative and cost-effective weight gain prevention tools; mobile applications (apps) represent one such solution. Using a randomized design, the mFIT study tests the effectiveness of using commercially available apps and a physical activity (PA) monitoring device (Tech, n=50 parent-child dyads) compared to the apps and PA device plus a mobile website and theory-based family intervention that encourages increased parent-child communication about PA and healthy eating as well as family behavior change (Tech+, n=50 parent-child dyads).

Condition or disease Intervention/treatment Phase
Obesity Behavioral: TECH Behavioral: TECH+ Phase 1

Detailed Description:

Objectives and Significance. Finding scalable and engaging ways to disseminate obesity treatment and prevention for children has been challenging. Mobile applications (apps) are an engaging way to involve children in health behavior changes, capitalizing on the portability and affordability of delivering health information via mobile devices and the opportunity to use gaming to make health information entertaining. Previous research by our team, including a systematic review of commercially available mobile apps for family weight loss, physical activity, and healthy eating as well as a pilot test of commercially available apps and physical activity monitoring devices with parent-child dyads, revealed significant gaps in the available mobile tools. The proposed study will test the effectiveness of using commercially available apps and a physical activity monitoring device (Tech) compared to the apps and physical activity device plus a mobile website and theory-based family intervention that encourages increased parent-child communication about physical activity and healthy eating and family behavior change (Tech+). The two programs will be administered remotely via email, mobile apps, and a mobile website to parent-child dyads (child 9-12 years old), using over a 3-month intervention period. Parent-child dyads will be randomized to the two behavioral interventions: Tech (50 dyads) or Tech+ (50 dyads). Our proposed research has two aims:

Aim 1: Test the effectiveness of an evidence-based mobile intervention with enhanced parent/child communication (Tech+) versus commercially available products (physical activity and healthy eating apps, physical activity device) alone (Tech) for improvements in physical activity and healthy eating in parents and children.

Aim 2: Examine the impacts of evidence-based family intervention on parent-child relationship quality and communication about physical activity and healthy eating.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Enhancing Parent-Child Communication and Promoting Physical Activity and Healthy Eating Through Mobile Technology: the mFIT Study (Motivating Families With Interactive Technology)
Study Start Date : February 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : December 2015

Arm Intervention/treatment
Active Comparator: TECH (standard program)

Receive 3-month healthy eating and physical activity intervention delivered via email newsletters and mobile apps plus self-monitoring with paper records; based on standard behavior change recommendations and materials (e.g., Diabetes Prevention Program)

Intervention: remotely-delivered evidence-based intervention to support healthy eating and physical activity; use of supporting app-based games and activities and self-monitoring.

Behavioral: TECH
Weekly newsletter with health information, mobile apps, and self-monitoring materials

Experimental: TECH+ (enhanced program)

Receive 3-month family-based healthy eating and physical activity intervention delivered via email newsletters and mobile apps plus self-monitoring with special study website

Intervention: remotely-delivered evidence-based intervention to support healthy eating and physical activity; use of supporting app-based games and activities; enhanced self-monitoring and family activities via special study website

Behavioral: TECH+
Weekly newsletter with health information, mobile apps, and self-monitoring materials along with theory-based mobile web intervention




Primary Outcome Measures :
  1. Bouts of moderate-to-vigorous physical activity (via accelorometers) [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participants must include 1 child (age 9-12) and their parent or guardian
  • Parent not currently meeting physical activity guidelines (participants will be eligible if they currently engage in aerobic activities for less than 2 hours and 30 minutes/week and strength training <2 days/week)
  • Own and use a smartphone and/or a tablet with a data plan (e.g., iPhone, iPad)
  • Live in the same household as the child
  • Are willing to be randomized to one of the two intervention groups
  • Willing and able to be physically active

Exclusion Criteria:

  • Has a psychiatric disease, drug or alcohol dependency, or uncontrolled thyroid condition
  • Has an eating disorder
  • Currently participating in a weight loss program or taking weight loss medications
  • Has a major chronic diseases, including: heart disease, past incidence of stroke, uncontrolled diabetes

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): NCT02361151


Locations
United States, South Carolina
University of South Carolina
Columbia, South Carolina, United States, 29208
Sponsors and Collaborators
University of South Carolina
Investigators
Study Chair: Gabrielle Turner-McGrievy, PhD, MS, RD University of South Carolina

Responsible Party: University of South Carolina
ClinicalTrials.gov Identifier: NCT02361151     History of Changes
Other Study ID Numbers: Pro00038855
First Posted: February 11, 2015    Key Record Dates
Last Update Posted: December 9, 2015
Last Verified: December 2015