Obesity Prevention Clinical Trial
Official title:
Helping Ethnically Diverse Teen Moms Prevent Obesity in Their Preschool Children
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.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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