Obesity Intervention for Low-Income African American Preschoolers

NCT02456623 | Completed DMC

• 1 other identifier: 1R03DK097444-01
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to preliminarily validate a parent-focused obesity intervention program for parents of low-income, African American preschoolers who are currently overweight (\> 85th BMI %tile). Half of the participants will receive an intervention that is eight sessions in length and carried out in the participant's home. The sessions will target the nutrition and physical activity knowledge of parents and their motivation for changing parenting related to family eating habits and activity level. The remaining participants will receive an attention comparison control condition (ACCC), which includes one home visit, 7 newsletters and 4 monthly support phone calls. It is hypothesized that children of parents receiving the intervention will have decreases in BMI %tile, consume more fruits/vegetables and fewer sugary beverages, and engage in more activity as compared to ACCC.

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (3)

• Change in Child Body Mass Index (BMI)

  Change in child BMI will be assessed between baseline and 5-month follow-up.

  5-months

• Change in child fruit, vegetable, and sugary beverage intake using the Block Food Frequency Questionnaire for children

  Change in child fruit and vegetable intake between baseline and 5-month follow-up will be collected using the Block Food Frequency Questionnaire for children.

  5-months

• Change in child physical activity level assessed using accelerometers

  Change in child's activity level between baseline and 5-month follow-up will be assessed using accelerometers, which will be worn for four days time at each assessment point.

  5-months

Secondary Outcomes (3)

• Change in parent nutrition/physical activity knowledge, assessed via a self-report survey

  5-months

• Change in parent motivation for health behavior change, assessed using the "readiness ruler"

  5-months

• Change in parenting Behavior, assessed using the Caregiver Feeding Style Questionnaire and the Parenting Young Children Scale

  5-months

Study Arms (2)

Intervention

EXPERIMENTAL

Behavioral intervention that targets the parent of a preschool age child who is overweight. The intervention is 8 sessions in length. Each session is expected to last 1-1.5 hours and will be carried out in the participant's home over 4 months. The sessions will target the nutrition and physical activity knowledge of parents and their motivation for changing parenting related to these factors. Intervention content for the parent will be based on Motivational Interviewing principles.

Behavioral: Intervention

Attention Control

ACTIVE COMPARATOR

The attention control condition includes 1 initial Motivational Interviewing (MI) session conducted in the home. The content of the MI session will be the same as for the intervention participants. Following this session, parents will receive bi-monthly newsletters that will include content similar to what intervention participants receive. AC participants will receive a total of 7 newsletters; 2 on nutrition, 2 on physical activity, 2 on parenting behavior and 1 on community resources. AC participants will also receive a monthly 20-min phone call designed to review newsletter content and answer parent questions.

Behavioral: Attention Control

Interventions

Intervention BEHAVIORAL

Home-based session targeting the parent

Intervention

Attention Control BEHAVIORAL

Attention condition with newsletters and support phone calls

Attention Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Parents of children enrolled in Head Start preschool in Detroit, MI will be included. Parents must be 18 years of age or older and their child must be of preschool age, between 3 and 5 years of age. Based on recruitment from Detroit Head Start, families will be low-income and of African American descent. Children will have a current body mass index percentile at or above the 85th percentile.

Sponsors & Collaborators

• Eastern Michigan University: lead

Study Sites (1)

Eastern Michigan University

Ypsilanti, Michigan, 48197, United States

Location

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Methods

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Heather C Janisse, Ph.D.

  Eastern Michigan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 8, 2015
• First Posted: May 28, 2015
• Study Start: September 1, 2013
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: December 12, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)