Clinical trial NCT03973424: Mobile Methods for Reducing Obesity Risk in Parents and Children
Official title: Mobile Methods for Reducing Obesity Risk in Parents and Children: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Overweight
Obesity
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: The Obesity Society
First posted: 2019-06-04
Enrollment: 144
Sex: ALL
Minimum age (years): 2
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percent weight loss: objective
timeFrame: Baseline, 6 Months
measure: Weight
timeFrame: Baseline, 6 Months
Secondary outcomes:
measure: Dietary tracking adherence
timeFrame: from Baseline to 6 Months
measure: Parent diet
timeFrame: Baseline, 6 Months
measure: Child diet
timeFrame: Baseline, 6 Months
measure: Percent weight loss: WiFi scale
timeFrame: Baseline, 3 Months, 6 Months
measure: Child BMI-percentile
timeFrame: Baseline, 6 Months
Other outcomes:
measure: Minutes of moderate-to-vigorous physical activity
timeFrame: Baseline, 3 Months, 6 Months
measure: Sedentary behavior
timeFrame: Baseline, 3 Months, 6 Months
measure: Physical food environment
timeFrame: Baseline, 3 Months, 6 Months
measure: Social food environment
timeFrame: Baseline, 3 Months, 6 Months
measure: Household food rules
timeFrame: Baseline, 3 Months, 6 Months
measure: Weight control self-efficacy
timeFrame: Baseline, 3 Months, 6 Months
measure: Self-efficacy for exercise
timeFrame: Baseline, 3 Months, 6 Months
measure: Self-regulation
timeFrame: Baseline, 3 Months, 6 Months
measure: Depressive symptoms
timeFrame: Baseline, 3 Months, 6 Months
measure: Stress
timeFrame: Baseline, 3 Months, 6 Months
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Brooke Nezami, PhD
role: PRINCIPAL_INVESTIGATOR
References: