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

Obesity Prevention Clinical Trial

— Project HERA  

Official title:

Helping Ethnically Diverse Teen Moms Prevent Obesity in Their Preschool Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02200484
• Other study ID #: 14864
• Secondary ID: R21HL114083
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 12, 2014
• Last updated: April 9, 2015
• Start date: April 2013
• Est. completion date: September 2014

Study information

• Verified date: April 2015
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 20 Years

Eligibility

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

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

Intervention

Behavioral:
• Combined parent training and obesity prevention program

• Wellness program (active contact control)

Locations

Country	Name	City	State
United States	UMass	Worcester	Massachusetts

Sponsors (6)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester	Brown University, National Heart, Lung, and Blood Institute (NHLBI), Rhode Island Hospital, The Miriam Hospital, University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Child Weight Status (BMI percentile)	We will measure child height and weight at baseline and 8-weeks follow up (end of treatment) to calculate child BMI percentile to assess for changes in BMI percentile for participants randomized during intervention piloting (n=46) to the adapted intervention condition (combined parenting/obesity prevention program) compared to those in the control condition (wellness program).	Baseline, 8-weeks follow up (end of treatment)	No
Primary	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)	No
Primary	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)	No
Secondary	Change in Child Problem Behavior	We will assess for changes in child problem behavior via maternal completion of child behavior questionnaires administered at baseline, once weekly for eight weeks during active intervention, and at 8 weeks end of treatment (follow up) for participants randomized (n= 46) to the intervention arm (parenting/combined obesity prevention program) versus control (wellness condition).	Baseline, Each week for 8 weeks during active treatment, and 8-weeks follow up (end of treatment)	No
Secondary	Change in Child Physical Activity/Sedentary Behavior	Child physical activity and sedentary behavior will be measured via maternal completion of questionnaires administered at baseline and 8 weeks follow up to assess for changes in these outcomes across participants randomized during intervention piloting (n=46) to the intervention condition (combined parenting/obesity prevention program) versus control condition (wellness program). Child physical activity and sedentary behavior will also be assessed via a home audit of the home physical activity/sedentary behavior environment completed by the research assistant at baseline and 8-weeks follow up (end of treatment)	Baseline, 8-weeks follow up (end of treatment)	No
Secondary	Change in Child fruit, Vegetable, Junk, Fat and Fast food Intake (Child Nutritional Behavior)	Child nutritional behavior will be measured via maternal completion of questionnaires administered at baseline and 8 weeks follow up to assess for changes in these outcomes across participants randomized during intervention piloting (n=46) to the adapted intervention condition (combined parenting/obesity prevention program) versus control condition (wellness program). Child nutritional behavior will also be assessed via a home audit completed by the research assistant at baseline and 8-weeks follow up (end of treatment).	Baseline, 8-weeks follow up (end of treatment)	No