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Healthy Home Offerings Via the Mealtime Environment (HOME) Plus

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ClinicalTrials.gov Identifier: NCT01538615
Recruitment Status : Completed
First Posted : February 24, 2012
Results First Posted : March 1, 2018
Last Update Posted : March 1, 2018
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: HOME Plus intervention Not Applicable

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 413 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: This is a behavioral intervention. Masking is not feasible.
Primary Purpose: Prevention
Official Title: Healthy Home Offerings Via the Mealtime Environment (HOME) Plus
Study Start Date : July 2010
Actual Primary Completion Date : July 2015
Actual Study Completion Date : June 2016

Arm Intervention/treatment
Experimental: HOME Plus Intervention
described below
Behavioral: 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
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 Outcome Measures :
  1. Change in Child Body Mass Index (BMI Z-score) [ Time Frame: Change from Baseline at 12 and 21 months ]
    Trained study staff will measure parent and child height and weight and use this to calculate body mass index (BMI). BMI values were than standardized for age and gender using CDC guidelines to obtain BMI z-scores. Analyses controlled for child age and parent education at baseline.


Secondary Outcome Measures :
  1. Change in Target Children's Daily Intakes of Fruits and Vegetables [ Time Frame: Change from Baseline at 12 and 21 months ]
    A trained interviewer will complete three 24-hour dietary recalls at each data collection time point with the child. The three days will be averaged to get an estimate of usual intake. Analyses controlled for child age and parent education at baseline.

  2. Change in Target Children's Hours of Screen Time (Television Viewing, Video and Computer Game Playing) Per Week [ Time Frame: Change from Baseline at 12 and 21 months ]
    Screen time will be measured with survey questions asking children how many hours per day they spend doing each sedentary activity (such as watching TV, using the computer, playing video games). Separate questions will be asked for week days and weekend days then the will be weighted to determine the hours of sedentary activity per week. Analyses controlled for child age and parent education at baseline.

  3. Change in Number of Fruits and Vegetables Available in the Home [ Time Frame: Change from Baseline at 12 and 21 months ]
    The HOME Food Inventory assesses which foods families currently have in their home from a list of items. Analyses controlled for child age and parent education.



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Ages Eligible for Study:   8 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01538615


Locations
United States, Minnesota
University of Minnesota, School of Nursing
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Jayne A Fulkerson, PhD University of Minnesota, School of Nursing

Additional Information:
Publications of Results:

Other Publications:
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01538615     History of Changes
Other Study ID Numbers: 20521
R01DK084000-01A2 ( U.S. NIH Grant/Contract )
First Posted: February 24, 2012    Key Record Dates
Results First Posted: March 1, 2018
Last Update Posted: March 1, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Family meals
Home food environment
Electronic media