Healthy Homes/Healthy Kids_5-9

NCT01084590 | Completed DMC

• 2 other identifiers: A08-1321R01DK084475
• Study Type: interventional
• Target: 421
• Locations: 1 country
• Sites: 2

Brief Summary

The pediatric primary care setting is a relatively untapped resource for addressing obesity prevention. The main goal of this study is to evaluate the efficacy of a relatively low cost pediatric primary-care based obesity prevention intervention. The intervention will consist of brief pediatrician counseling as well as phone coaching for parents with overweight children who are between the ages of five and nine. We propose to enroll and randomize 425 parent-child dyads with children who have a measured body mass index (BMI) the 75th and 95th percentile. They will be randomized one of into two groups, the (a) Healthy Eating/Physical Activity Intervention, or the (b) General Healthy/Safety/Injury Prevention Contact Control Intervention. Both groups will receive brief pediatrician counseling regarding their child's current BMI percentile status and recommendations for home environmental changes to achieve a healthy weight gain trajectory and to improve home safety and reduce injury risk. This will be paired with a 12 month home-based program delivered via phone by health behavior specialists to help parents make environmental changes specific to their group assignment.

Conditions

Obesity; Injury

Keywords

Prevention; Obesity; Safety; Unhealthy weight gain; Injury prevention

Outcome Measures

Primary Outcomes (1)

• BMI percentile change

  Children at risk for obesity (defined as having a BMI%ile between the 75th and 85th%ile) whose parent participates in the Healthy Eating/Physical Activity Intervention will have a significantly lower BMI percentile at 12 and 24 month-follow up when compared to children whose parents participated in the Safety/Injury Prevention Intervention.

  24 months

Secondary Outcomes (4)

• Dietary intake and activity patterns

  24 months

• Parenting behaviors

  24 months

• BMI percentile and psychosocial adjustment

  24 months

• Parent BMI

  24 months

Study Arms (2)

Healthy Eating/Physical Activity

EXPERIMENTAL

This intervention arm will include brief pediatrician counseling regarding the child's current BMI percentile status, recommendations for home environmental changes to achieve a healthy weight gain trajectory, and home safety and injury risk reduction environmental recommendations paired with a 12 month home-based program delivered via phone by a masters-level health behavior specialist to promote implementation of the obesity prevention home environmental strategies.

Behavioral: Healthy Eating/Physical Activity

Safety/Injury Prevention

ACTIVE COMPARATOR

This intervention arm will include the same brief counseling from the pediatrician paired with a 12 month home-based program delivered via phone by a masters-level health behavior specialist to promote implementation of the safety and injury prevention home environmental strategies.

Behavioral: Safety/Injury Prevention

Interventions

Healthy Eating/Physical Activity BEHAVIORAL

This intervention arm will include brief pediatrician counseling regarding the child's current BMI percentile status, recommendations for home environmental changes to achieve a healthy weight gain trajectory, and home safety and injury risk reduction environmental recommendations paired with a 12 month home-based program delivered via phone by a masters-level health behavior specialist to promote implementation of the obesity prevention home environmental strategies.

Healthy Eating/Physical Activity

Safety/Injury Prevention BEHAVIORAL

This intervention arm will include the same brief counseling from the pediatrician paired with a 12 month home-based program delivered via phone by a masters-level health behavior specialist to promote implementation of the safety and injury prevention home environmental strategies.

Safety/Injury Prevention

Eligibility Criteria

• Age: 5 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• BMI%ile between the 75th and 95th%ile
• Receives care at a HealthPartners Clinic in the Twin Cities Metropolitan Area

You may not qualify if:

• Children with the following chronic conditions: kidney disease, Type 1 diabetes, lupus, a thyroid condition, cancer, or chromosomal abnormality such as Down's syndrome or Turner's syndrome
• Children who within the last six months or those who are currently taking the following medications and took them or will be taking them for more than a month: Prednisone, Prednisilone, and Decadron.
• Families who have limited English skills.
• Families who plan to move out of the metropolitan area within the next two years.

Sponsors & Collaborators

• HealthPartners Institute: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• University of Washington: collaborator
• University of Minnesota: collaborator

Study Sites (2)

HealthPartners Research Foundation

Bloomington, Minnesota, 55425, United States

Location

University of Washington School of Social Work

Seattle, Washington, 98105, United States

Location

Related Publications (3)

• JaKa MM, French SA, Wolfson J, Jeffery RW, Lorencatto F, Michie S, Levy RL, Langer SL, Sherwood NE. Understanding Outcomes in Behavior Change Interventions to Prevent Pediatric Obesity: The Role of Dose and Behavior Change Techniques. Health Educ Behav. 2019 Apr;46(2):312-321. doi: 10.1177/1090198118798679. Epub 2018 Sep 14.

  PMID: 30215279 DERIVED

• Kunin-Batson AS, Seburg EM, Crain AL, Jaka MM, Langer SL, Levy RL, Sherwood NE. Household factors, family behavior patterns, and adherence to dietary and physical activity guidelines among children at risk for obesity. J Nutr Educ Behav. 2015 May-Jun;47(3):206-15. doi: 10.1016/j.jneb.2015.01.002. Epub 2015 Mar 4.

  PMID: 25748634 DERIVED

• Sherwood NE, Levy RL, Langer SL, Senso MM, Crain AL, Hayes MG, Anderson JD, Seburg EM, Jeffery RW. Healthy Homes/Healthy Kids: a randomized trial of a pediatric primary care-based obesity prevention intervention for at-risk 5-10 year olds. Contemp Clin Trials. 2013 Sep;36(1):228-43. doi: 10.1016/j.cct.2013.06.017. Epub 2013 Jun 28.

  PMID: 23816490 DERIVED

MeSH Terms

Conditions

Obesity; Wounds and Injuries

Interventions

Diet, Healthy; Exercise; Safety

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Accident Prevention; Accidents; Public Health; Environment and Public Health

Study Officials

• Nancy E Sherwood, PhD

  HealthPartners Institute

  PRINCIPAL INVESTIGATOR

• Rona L Levy, PhD

  University of Washington School of Social Work

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2010
• First Posted: March 10, 2010
• Study Start: March 1, 2010
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: March 27, 2015

Record last verified: 2015-03

Locations

US (2)