Project HERA (Health, Education, and Relationship-building for Adolescents- Moms and Tots) — Project HERA  

Obesity Prevention Clinical Trial

Official title: Helping Ethnically Diverse Teen Moms Prevent Obesity in Their Preschool Children

Status Completed

Clinical Trial Summary

Specific Aims:

1. The primary aims of this study are to conduct formative interviews with teen mothers to inform a targeted adaptation of empirically based weight management and parent training programs for teen mothers for their preschoolers.

2. To conduct a small pilot and post-pilot focus group of the feasibility and acceptability of recruitment and retention methods & the intervention.

Study Hypotheses:

Given the small sample size and fact that this is a pilot study, focus will be on estimating effect sizes rather than statistical hypothesis testing. However, the investigators exploratory hypotheses are as follows:

1. (a) The adapted intervention will be more feasible compared to the wellness control condition, with a participant retention rate of ≥80% and an average adherence (attendance at weekly treatment sessions; homework completion 5 weekdays weekly) is ≥ 75%; (b) The adapted intervention will be more acceptable compared to the wellness control condition, based on the Consumer Satisfaction Scale and Therapy Assessment Inventory with ≥90% of the participants responding to the item, "In general how satisfied were you with the intervention?" by choosing "unsatisfied" to "very satisfied."

2. (a) The adapted intervention will result in greater improvements in child behavior and parent-child connectedness compared to the control condition; (b) the adapted intervention versus wellness control condition will result in greater increases in child and teen mother individual as well as joint physical activity and physically active play and greater reductions in individual and joint teen mother and child sedentary behavior (television viewing) from baseline to post-intervention; (c) the greater teen mother and child fruit and vegetable consumption; and reduced child juice and sugar-sweetened beverage consumption from baseline to post-intervention; (d) the adapted intervention versus wellness control condition will result in smaller increases in child BMI percentile and teen mother BMI from baseline to post-intervention; (e) participants who attend higher numbers of intervention sessions will show greater improvements in target outcomes (child behavior, parent-child connectedness, and teen mother and child physical activity, sedentary behavior and BMI); with participants receiving the adapted intervention versus wellness control showing the greatest dose-based improvements.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Child Behavior Problems
• Obesity Prevention
• Parenting Skills

• NCT number: NCT02200484
• Study type: Interventional
• Source: University of Massachusetts, Worcester
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 2013
• Completion date: September 2014