Clinical trial NCT02200484: Project HERA (Health, Education, and Relationship-building for Adolescents- Moms and Tots)
Official title: Helping Ethnically Diverse Teen Moms Prevent Obesity in Their Preschool Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Child Behavior Problems
Parenting Skills
Obesity Prevention
Keywords: obesity
adolescents, females
child development
weight loss programs
child rearing
parenting
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: Brown University
name: Rhode Island Hospital
name: The Miriam Hospital
name: University of South Carolina
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2014-07-25
Enrollment: 25
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Study Feasibility
timeFrame: Measured at the beginning of participant recruitment through 8 weeks follow up (end of treatment)
measure: Study Acceptability
timeFrame: 8-weeks follow up (end of treatment)
Secondary outcomes:
measure: Change in Child Problem Behavior
timeFrame: Baseline, Each week for 8 weeks during active treatment, and 8-weeks follow up (end of treatment)
measure: Change in Child Physical Activity/Sedentary Behavior
timeFrame: Baseline, 8-weeks follow up (end of treatment)
measure: Change in Child fruit, Vegetable, Junk, Fat and Fast food Intake (Child Nutritional Behavior)
timeFrame: Baseline, 8-weeks follow up (end of treatment)
Other outcomes:
measure: Change in Child Weight Status (BMI percentile)
timeFrame: Baseline, 8-weeks follow up (end of treatment)
Locations:
city: Worcester
country: United States
facility: UMass
state: Massachusetts
Study officials:
References: