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NCT02200484 · ClinicalTrials.gov registry record · Phase 1
Project HERA (Health, Education, and Relationship-building for Adolescents- Moms and Tots)
A Phase 1 study, sponsored by University of Massachusetts, Worcester.
- Completed
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
NCT02200484 is a Phase 1 study that has completed, run by University of Massachusetts, Worcester. The registered enrollment target is 25 participants.
The verdict
NCT02200484, a Phase 1 study, has completed, sponsored by University of Massachusetts, Worcester.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
Study 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 percentil
Interventions
- BEHAVIORAL Combined parent training and obesity prevention program
- BEHAVIORAL Wellness program (active contact control)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2013-04 |
| Est. Completion | 2014-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02200484
The ClinicalTrials.gov registry entry for NCT02200484 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Massachusetts, Worcester, which has 240 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Combined parent training and obesity prevention program is the first listed.
NCT02200484 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02200484 about?
NCT02200484 is a clinical study titled "Project HERA (Health, Education, and Relationship-building for Adolescents- Moms and Tots)". 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 ...
What is the current status of trial NCT02200484?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2013-04. Estimated completion is 2014-09.
What interventions are being tested in trial NCT02200484?
The interventions under investigation include: Combined parent training and obesity prevention program (BEHAVIORAL), Wellness program (active contact control) (BEHAVIORAL).
Who is sponsoring clinical trial NCT02200484?
This trial is sponsored by University of Massachusetts, Worcester, which has 240 total clinical trials registered on ClinicalTrials.gov.
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