Mobile Methods for Reducing Obesity Risk in Parents and Children

NCT03973424 | Completed

• 1 other identifier: 17-3027
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity; Overweight; Obesity

Outcome Measures

Primary Outcomes (2)

• Percent weight loss: objective

  Weight change from baseline to 6 months calculated as a percent from baseline weight.

  Baseline, 6 Months

• Weight

  Absolute weight change from baseline to 6 months.

  Baseline, 6 Months

Secondary Outcomes (5)

• Dietary tracking adherence

  from Baseline to 6 Months

• Parent diet

  Baseline, 6 Months

• Child diet

  Baseline, 6 Months

• Percent weight loss: WiFi scale

  Baseline, 3 Months, 6 Months

• Child BMI-percentile

  Baseline, 6 Months

Other Outcomes (10)

• Minutes of moderate-to-vigorous physical activity

  Baseline, 3 Months, 6 Months

• Sedentary behavior

  Baseline, 3 Months, 6 Months

• Physical food environment

  Baseline, 3 Months, 6 Months

Study Arms (2)

Simple

EXPERIMENTAL

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.

Behavioral: Simple

Standard

EXPERIMENTAL

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.

Behavioral: Standard

Interventions

Simple 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.

Simple

Standard 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.

Standard

Eligibility Criteria

• Age: 2 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• The Obesity Society: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

• 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.

  PMID: 38375882 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Brooke Nezami, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2019
• First Posted: June 4, 2019
• Study Start: August 14, 2019
• Primary Completion: May 6, 2020
• Study Completion: May 21, 2020
• Last Updated: June 16, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)