Mobile Methods for Reducing Obesity Risk in Parents and Children: A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Weight
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Currently age 21-
- •Body mass index (BMI) of 25-50 kg/m².
- •Have one child between the ages of 2-
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Simple (Behavioral)
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.
干预措施: Standard (Behavioral)
结局指标
主要结局
Weight
时间窗: Baseline, 6 Months
Absolute weight change from baseline to 6 months.
Percent weight loss: objective
时间窗: Baseline, 6 Months
Weight change from baseline to 6 months calculated as a percent from baseline weight.
次要结局
- 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)