Mobile Methods for Reducing Obesity Risk in Parents and Children

Study Overview
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Brief Summary
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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
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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.

Official Title
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Mobile Methods for Reducing Obesity Risk in Parents and Children: A Randomized Trial

Conditions
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Overweight and Obesity, Overweight, Obesity

Intervention / Treatment
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* Behavioral: Simple
* Behavioral: Standard


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (parent): 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. Inclusion Criteria (child): Currently age 2-12. Exclusion Criteria (parent): 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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Simple<br>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<br>* 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.<br>|
| Experimental: Standard<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dietary tracking adherence | Number of days of complete dietary tracking summed over the 6-month study period. | from Baseline to 6 Months | 
| Parent diet | Change in parent daily caloric intake as measured by 24-hour dietary recall from baseline to 6 months. | Baseline, 6 Months | 
| Child diet | Change in child daily caloric intake as measured by 24-hour dietary recall from baseline to 6 months. | Baseline, 6 Months | 
| Percent weight loss: WiFi scale | Weight change calculated as a percent from baseline weight (measured in kg), using official assessment weights taken from participants' study-provided WiFi-enabled weighing scale and transmitted via WiFi, from baseline to 3, and 6 months. | Baseline, 3 Months, 6 Months | 
| Child BMI-percentile | Change in child BMI-percentile using at-home measurements of child's weight (on parent WiFi-enabled scale) and height | Baseline, 6 Months |