Mobile Methods for Reducing Obesity Risk in Parents and Children

NCT ID: NCT03973424

Last Updated: 2020-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-14
• Study Completion Date: 2020-05-21

Brief Summary

The purpose of this study is to test the efficacy of an innovative 6-month smartphone-delivered intervention using simplified monitoring of dietary intake compared to a smartphone-delivered intervention with standard calorie monitoring among parents with overweight or obesity.

Detailed Description

This is a 6-month randomized controlled trial comparing the efficacy of two smartphone-based dietary and weight change interventions among 70 parent-child dyads with at least one child between the ages of 2 and 12 (70 adults and 70 children ages 2-12). One intervention group (Simple) will use a simplified, low-burden form of dietary tracking in the study smartphone application and the other group (Standard) will use standard calorie tracking. Components of both interventions include (1) setting personalized goals for weight, dietary intake, and daily activity (2) adaptive text message interventions based on behavior change techniques such as goal setting and in-the-moment progress feedback several times per week, (3) weekly tailored feedback updated in the study smartphone app, and (4) weekly lessons on the smartphone app. The primary objective is to promote weight loss in the parents, and the secondary objective is to determine if one or both interventions produce a ripple effect of parent dietary change onto dietary changes in the child.

Conditions

Overweight and Obesity; Overweight; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Simple

This arm uses a simplified form of dietary tracking that involves tracking only high-calorie, high-fat foods, in addition to the core behavioral smartphone-delivered intervention that consists of weighing, physical activity, goal setting, adaptive text messages, tailored weekly feedback, and lessons.

Group Type: EXPERIMENTAL

Simple

Intervention Type: BEHAVIORAL

Participants have three daily goals (weighing, dietary goal, activity goal), will self-monitor (weigh on Wi-Fi enabled scale, use a simplified form of tracking only high-calorie, high-fat foods in the study smartphone app, wear Fitbit activity tracker), will receive 4-5 tailored text messages each week, and will view weekly tailored feedback and lessons in smartphone app.

Standard

This arm uses standard calorie tracking, in addition to the core behavioral smartphone-delivered intervention that consists of weighing, physical activity, goal setting, adaptive text messages, tailored weekly feedback, and lessons.

Group Type: EXPERIMENTAL

Standard

Intervention Type: BEHAVIORAL

Participants have three daily goals (weighing, dietary goal, activity goal), will self-monitor (weigh on Wi-Fi enabled scale, track calorie intake, wear Fitbit activity tracker), will receive 4-5 tailored text messages each week, and will view weekly tailored feedback and lessons in smartphone app.

Interventions

Simple

Participants have three daily goals (weighing, dietary goal, activity goal), will self-monitor (weigh on Wi-Fi enabled scale, use a simplified form of tracking only high-calorie, high-fat foods in the study smartphone app, wear Fitbit activity tracker), will receive 4-5 tailored text messages each week, and will view weekly tailored feedback and lessons in smartphone app.

Intervention Type: BEHAVIORAL

Standard

Participants have three daily goals (weighing, dietary goal, activity goal), will self-monitor (weigh on Wi-Fi enabled scale, track calorie intake, wear Fitbit activity tracker), will receive 4-5 tailored text messages each week, and will view weekly tailored feedback and lessons in smartphone app.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Currently age 21-55.
• Body mass index (BMI) of 25-50 kg/m².
• Have one child between the ages of 2-12.
• Own an iPhone running at least iOS11 with a data and text messaging plan.
• Have the ability to read, write, and speak English.

• Currently age 2-12.

Exclusion Criteria

• Lost more than 10 pounds in the last 6 months.
• Currently participating in another nutrition or weight loss program.
• Currently meeting exercise recommendations of 150 minutes per week of moderate-to-vigorous physical activity.
• Currently pregnant or breastfeeding, pregnant within the past 6 months, or planning to become pregnant within the next 6 months.
• Planning to relocate in the next 8 months.
• Will be out of town for 2 weeks or more in the next 8 months.
• Cannot attend two visits at the UNC Weight Research Program clinic.
• Pre-existing medical condition(s) that preclude adherence to an unsupervised exercise program, as determined by items endorsed on the PAR-Q (Physical Activity Readiness Questionnaire).
• Treatment of diabetes with insulin or oral medications that may cause hypoglycemia.
• History of clinically diagnosed eating disorder.
• Diagnosis of schizophrenia or bipolar disorder.
• Hospitalization for a psychiatric diagnosis within the last year.
• Report a past diagnosis of or current symptoms of alcohol or substance dependence.
• Another member of the household (family member or roommate) is a participant or staff member in this study.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Obesity Society

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brooke Nezami, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 38375882 (View on PubMed)

Other Identifiers

17-3027

Identifier Type: -

Identifier Source: org_study_id