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

NCT ID: NCT02200484

Last Updated: 2015-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2014-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Parent Training/Obesity Prevention

Mother-child dyads randomized to the active intervention in the pilot study will be administered 8 weeks of a combined parenting training and obesity prevention program that was adapted through analysis of formative research interviews with adolescent mothers with feedback from an expert panel of multidisciplinary research team members and community members.

Group Type: EXPERIMENTAL

Combined parent training and obesity prevention program

Intervention Type: BEHAVIORAL

8-week Wellness Program (Control)

Participants randomized to control condition during intervention piloting will receive print-based health and wellness materials once weekly for 8-weeks + 2 follow up telephone calls at the beginning and conclusion of the 8-week program.

Group Type: ACTIVE_COMPARATOR

Wellness program (active contact control)

Intervention Type: BEHAVIORAL

Interventions

Combined parent training and obesity prevention program

Intervention Type: BEHAVIORAL

Wellness program (active contact control)

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Must be teen moms
• Be between 16 and 20 years of age

Exclusion Criteria

• Does not have a child between the ages of 6 months and 5 years

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Brown University

OTHER

Sponsor Role: collaborator

Rhode Island Hospital

OTHER

Sponsor Role: collaborator

The Miriam Hospital

OTHER

Sponsor Role: collaborator

University of South Carolina

OTHER

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Massachusetts, Worcester

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UMass

Worcester, Massachusetts, United States

Countries

United States

Other Identifiers

R21HL114083

Identifier Type: NIH

Identifier Source: secondary_id

View Link

14864

Identifier Type: -

Identifier Source: org_study_id