Rationale, design, methodology and sample characteristics for the family partners for health study: a cluster
Diane C Berry1, Robert McMurray, Todd A Schwartz
1School of Nursing, The University of North Carolina at Chapel Hill, Campus Box 7460, Chapel Hill, NC 27599-7460, USA. dberry@email.unc.edu
Insights
This study investigated a lifestyle intervention for overweight children and parents. Findings may help families improve nutrition and exercise for better health outcomes.
Area of Science:
- Pediatric Health
- Public Health Interventions
- Obesity Research
Background:
- Overweight children face increased risks of obesity, type 2 diabetes, and cardiovascular disease.
- Early intervention is critical to mitigate long-term health consequences.
- A 5-year cluster randomized controlled trial was conducted in rural North Carolina.
Purpose of the Study:
- To examine the effects of a two-phased intervention on weight status, adiposity, nutrition, exercise, and self-efficacy in overweight/obese children and parents.
- To investigate relationships between parent and child changes in health behaviors and weight status within the intervention group.
- To explore differential benefits of the intervention across ethnic groups (African American, Hispanic, non-Hispanic white).
Main Methods:
- A cluster randomized controlled trial involving 358 children (BMI ≥ 85th percentile) and 358 parents (BMI ≥ 25 kg/m²).
- The intervention included a 12-week intensive program (nutrition, exercise, coping skills) followed by 9 months of contact and 6 months of follow-up.
- Primary outcomes: stabilization of BMI percentile trajectory in children and BMI decrease in parents at 18 months. Secondary outcomes: adiposity, health behaviors, and self-efficacy.
Main Results:
- The study enrolled a diverse cohort of 358 children and 358 parents over 3.5 years.
- Participants were randomized to an experimental or wait-listed control group.
- Intention-to-treat analysis will be applied to assess outcomes.
Conclusions:
- The trial's findings may inform effective interventions for families to collaboratively improve nutrition and exercise.
- Small lifestyle changes can contribute to better health patterns in children and parents.
- This research may lead to strategies for preventing childhood obesity and related diseases.
Background:
Young children who are overweight are at increased risk of becoming obese and developing type 2 diabetes and cardiovascular disease later in life. Therefore, early intervention is critical. This paper describes the rationale, design, methodology, and sample characteristics of a 5-year cluster randomized controlled trial being conducted in eight elementary schools in rural North Carolina, United States.
Methods/Design:
The first aim of the trial is to examine the effects of a two-phased intervention on weight status, adiposity, nutrition and exercise health behaviors, and self-efficacy in overweight or obese 2nd, 3 rd, and 4th grade children and their overweight or obese parents. The primary outcome in children is stabilization of BMI percentile trajectory from baseline to 18 months. The primary outcome in parents is a decrease in BMI from baseline to 18 months. Secondary outcomes for both children and parents include adiposity, nutrition and exercise health behaviors, and self-efficacy from baseline to 18 months. A secondary aim of the trial is to examine in the experimental group, the relationships between parents and children's changes in weight status, adiposity, nutrition and exercise health behaviors, and self-efficacy. An exploratory aim is to determine whether African American, Hispanic, and non-Hispanic white children and parents in the experimental group benefit differently from the intervention in weight status, adiposity, health behaviors, and self-efficacy.A total of 358 African American, non-Hispanic white, and bilingual Hispanic children with a BMI ≥ 85th percentile and 358 parents with a BMI ≥ 25 kg/m² have been inducted over 3 1/2 years and randomized by cohort to either an experimental or a wait-listed control group. The experimental group receives a 12-week intensive intervention of nutrition and exercise education, coping skills training and exercise (Phase I), 9 months of continued monthly contact (Phase II) and then 6 months (follow-up) on their own. Safety endpoints include adverse event reporting. Intention-to-treat analysis will be applied to all data.
Discussion:
Findings from this trial may lead to an effective intervention to assist children and parents to work together to improve nutrition and exercise patterns by making small lifestyle pattern changes.
Trial Registration:
NCT01378806.
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