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

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.

Conditions

• Child Behavior Problems
• Parenting Skills
• Obesity Prevention

Interventions

BEHAVIORAL

Combined parent training and obesity prevention program

BEHAVIORAL

Wellness program (active contact control)

Sponsors & Collaborators

• Brown University

  collaborator OTHER

• Rhode Island Hospital

  collaborator OTHER

• The Miriam Hospital

  collaborator OTHER

• University of South Carolina

  collaborator OTHER

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• University of Massachusetts, Worcester

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

16 Years

Max Age

20 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-04-30

Primary Completion

2014-09-30

Completion

2014-09-30

Countries

• United States

Study Locations