NCT02361151

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Feb 2015

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 3, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 11, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 18, 2019

Status Verified

April 1, 2019

Enrollment Period

6 months

First QC Date

February 3, 2015

Last Update Submit

April 16, 2019

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Bouts of moderate-to-vigorous physical activity (via accelorometers)

    12 weeks

Study Arms (2)

TECH (standard program)

ACTIVE COMPARATOR

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

TECH+ (enhanced program)

EXPERIMENTAL

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+

Interventions

TECH+BEHAVIORAL

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

TECH+ (enhanced program)

Eligibility Criteria

Age9 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29208, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gabrielle Turner-McGrievy, PhD, MS, RD

    University of South Carolina

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Advisor

Study Record Dates

First Submitted

February 3, 2015

First Posted

February 11, 2015

Study Start

February 1, 2015

Primary Completion

August 1, 2015

Study Completion

December 1, 2015

Last Updated

April 18, 2019

Record last verified: 2019-04

Locations

US(1)