The mFIT Study (Motivating Families With Interactive Technology)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

FIT Families Multicomponent Obesity Intervention for African American Adolescents

NCT04974554

Obesity, Childhood Metabolic Syndrome

ACTIVE_NOT_RECRUITING NA

Increased Monitoring of Physical Activity and Calories With Technology

NCT03961061

Weight Change, Body Behavior, Health Obesity, Childhood +1 more

COMPLETED NA

Improving Parent-Child Interactions to Enhance Child Health

NCT03982511

Child Obesity

COMPLETED NA

An Interactive Web-based Intervention to Achieve Healthy Weight in Young Children

NCT01552642

Child Obesity Overweight

COMPLETED PHASE3

Toddler Overweight Prevention Study Among Low-Income Families

NCT02615158

Overweight Obesity Depression

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

TECH

Intervention Type BEHAVIORAL

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

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

Group Type EXPERIMENTAL

TECH+

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TECH

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

Intervention Type BEHAVIORAL

TECH+

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes