Overview

This trial is active, not recruiting.

Condition obesity
Treatment home plus intervention
Sponsor University of Minnesota - Clinical and Translational Science Institute
Collaborator National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date July 2010
End date July 2015
Trial size 380 participants
Trial identifier NCT01538615, 20521, R01DK084000-01A2

Summary

The goal of the proposed project is to see if an innovative family-based intervention can reduce childhood obesity by actively engaging the whole family in promoting healthy behaviors in the home. In additions, the project will also examine how the HOME Plus family intervention influences children's dietary intake, frequency of family meals, availability of healthy and unhealthy foods in the home and served at meals and snacks, and screen time (TV, game systems). The study will provide important information on strategies that families can use at home to prevent obesity.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
described below
home plus intervention
The HOME Plus program families will participate in monthly, two-hour group sessions for ten months at local community centers. Each session offers new ideas focusing on family meals, healthy eating, and reducing sedentary behavior. At each session, families prepare and eat a meal together and participate in small group discussions and activities for both parent and child groups to promote healthy behaviors in the home. Topics include planning healthy meals and snacks with your family, having meals with your family more often, and improving the healthfulness of the food available at home. Families also receive periodic supportive phone calls throughout the year using motivational interviewing techniques to promote healthy behaviors to prevent and reduce childhood obesity.
(No Intervention)
Control participants receive a monthly newsletter for the 10 months of the study with tips on healthy eating. The topics do not overlap the intervention content.

Primary Outcomes

Measure
Change in Body Mass Index
time frame: baseline, 12 months, 21 months

Secondary Outcomes

Measure
Change in frequency of weekly family meals
time frame: baseline, 12 months, 21 months
Change in target children's daily intakes of healthful foods and beverages
time frame: baseline, 12 months, 21 months
Change in target children's minutes of sedentary behavior per week, particularly screen time (television viewing, video and computer game playing)
time frame: baseline, 12 months, 21 months
Change in number of healthful foods and beverages available in the home and served at family meals and snacks
time frame: baseline, 12 months, 21 months

Eligibility Criteria

Male or female participants at least 8 years old.

Inclusion Criteria: - the target child is between the ages of 8-12 years - the target adult parent or guardian is the primary food preparer in the home - target child has an age and gender adjusted body mass index at or above the 50th percentile - participants are willing to be randomized into one of two groups (intervention or control) - target child must live with participating adult most of the time Exclusion Criteria: - participants plan to move out of the area in the next six months - participants have a severe food allergy, limitation, or medical condition that prevents them from participating in the intervention - participants do not speak and read in English

Additional Information

Official title Healthy Home Offerings Via the Mealtime Environment (HOME) Plus
Principal investigator Jayne A Fulkerson, PhD
Description Childhood obesity is a serious public health problem with limited effective prevention strategies to date. Although previous nutrition and physical activity environmental approaches for obesity prevention show some promise, most studies have not shown reductions in excess weight gain. Moreover, few prevention studies significantly engage parents and focus on the home environment. To prevent childhood obesity it is essential to promote healthy behaviors in the home environment because parents are influential primary role models for healthy eating and sedentary behavior, and are gatekeepers for food and beverage availability and degree of inactivity within the home. Moreover, the home setting is where most of children's calories and energy dense foods are consumed and where children engage in much of their sedentary behavior, particularly screen time (e.g., television, computer, game system). The proposed study will test the efficacy of the Healthy Home Offerings via the Mealtime Environment (HOME) Plus program, a ten-month, family-based health promotion intervention to prevent excess weight gain among 8-12 year old children. The program is based on Social Cognitive Theory and a socio-ecological framework and promotes both regular and nutritionally-sound snacks and meals in which family members eat together (i.e., family meals) and encourages reductions in sedentary behavior, particularly screen time among children in the home setting. The efficacy of the intervention will be tested in a randomized controlled trial with 160 families randomized to two conditions (intervention or attention-only control). Two cohorts of families, recruited from after-school programs and community centers, will be followed for 2.5 years. The primary hypothesis is that, by the end of the ten month intervention, target children in the intervention families, relative to children in the control families, will have significantly lower body mass index (BMI; primary outcome) after adjustment for baseline BMI values. Secondary outcomes include frequency of weekly family meals and number of healthful foods and beverages available in the home and served at family meals and snacks (as reported by parent), target children's daily intakes of healthful foods and beverages, and target children's minutes of sedentary behavior per week, particularly screen time. Child and parent measurement will occur in their homes at baseline, post-intervention (12-months post-randomization), and follow-up (9-months post-intervention) by trained research staff. The proposed study builds upon successful methods from our HOME pilot study (2006-2008; NIH R21-DK0072997) and is innovative as it actively engages entire families in experiential activities and capitalizes on the home setting. The study will provide important information on environmental and behavioral strategies that families can use at home to prevent excess weight gain. The intervention program has high translation potential and is likely to be immediately useful to families of school-age children because it will be tested in real-world community settings and sustained across the state of Minnesota by the University of Minnesota's Extension Service.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by University of Minnesota - Clinical and Translational Science Institute.