Healthy Home Offerings Via the Mealtime Environment (HOME) Plus

University of Minnesota (UMN)

Status: Completed

Conditions: Obesity

Treatments: Behavioral: HOME Plus intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01538615

20521

R01DK084000-01A2 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 413 patients

Sex: All

Ages: 8+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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413 participants in 2 patient groups

HOME Plus Intervention

Experimental group

Description:

described below

Treatment:

Behavioral: HOME Plus intervention

Control

No Intervention group

Description:

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.