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

NCT02200484 | Completed Phase 1 DMC

• 2 other identifiers: 14864R21HL114083
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Specific Aims:

1. 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. 2.To conduct a small pilot and post-pilot focus group of the feasibility and acceptability of recruitment and retention methods \& the intervention.
3. 3.(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."
4. 4.(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

Keywords

obesity; adolescents, females; child development; weight loss programs; child rearing; parenting

Outcome Measures

Primary Outcomes (2)

• Study Feasibility

  Feasibility will be assessed during intervention piloting using process evaluation data to determine the pace of recruitment relative to sample size goals and differences in retention by condition. Descriptive analyses will determine the % of participants recruited, rate of accrual, attrition rate over time and total, % accepting randomization to treatment, and % compliance with study protocols (as measured by number of sessions attended, number who complete homework, etc…). Due to the small sample size in the current study, the intervention will be considered feasible if the retention rate is ≥ 80% and if the average adherence (attendance at weekly treatment sessions; homework completion 5 weekdays weekly) is ≥ 75%. The post pilot focus group will probe participants about their perspective on methods used to recruitment them into the study, including advertisements, incentives, location etc...

  Measured at the beginning of participant recruitment through 8 weeks follow up (end of treatment)

• Study Acceptability

  We will assess study acceptability via maternal completion of customer satisfaction questionnaires at the end of treatment (8 weeks follow up) for participants randomized (n=46) during intervention piloting to the adapted intervention (combined parenting/obesity prevention program) versus control condition (wellness program). We will invite a subsample of n=8 adolescent mothers to participate in the post-pilot focus group to further assess study acceptability and probe these participants on the likes and dislikes for the program, and recruitment methods.

  8-weeks follow up (end of treatment)

Secondary Outcomes (3)

• Change in Child Problem Behavior

  Baseline, Each week for 8 weeks during active treatment, and 8-weeks follow up (end of treatment)

• Change in Child Physical Activity/Sedentary Behavior

  Baseline, 8-weeks follow up (end of treatment)

• Change in Child fruit, Vegetable, Junk, Fat and Fast food Intake (Child Nutritional Behavior)

  Baseline, 8-weeks follow up (end of treatment)

Other Outcomes (1)

• Change in Child Weight Status (BMI percentile)

  Baseline, 8-weeks follow up (end of treatment)

Study Arms (2)

Parent Training/Obesity Prevention

EXPERIMENTAL

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.

Behavioral: Combined parent training and obesity prevention program

8-week Wellness Program (Control)

ACTIVE COMPARATOR

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.

Behavioral: Wellness program (active contact control)

Interventions

Combined parent training and obesity prevention program BEHAVIORAL

Parent Training/Obesity Prevention

Wellness program (active contact control) BEHAVIORAL

8-week Wellness Program (Control)

Eligibility Criteria

• Age: 16 Years - 20 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• Brown University: collaborator
• Rhode Island Hospital: collaborator
• The Miriam Hospital: collaborator
• University of South Carolina: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

UMass

Worcester, Massachusetts, 01655, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Health Promotion

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2014
• First Posted: July 25, 2014
• Study Start: April 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: April 10, 2015

Record last verified: 2015-04

Locations

US (1)