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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: Completed Phase 1 study, sponsored by University of Massachusetts, Worcester.

NCT02200484 is a Phase 1 study that has completed, run by University of Massachusetts, Worcester. The registered enrollment target is 25 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

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 sam

Interventions

  • BEHAVIORAL Combined parent training and obesity prevention program
  • BEHAVIORAL Wellness program (active contact control)

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2013-04
Est. Completion 2014-09
Phase Phase 1

What the finished NCT02200484 record still lists

NCT02200484 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower).

The record links to 0 conditions, and to 2 interventions - of which Combined parent training and obesity prevention program is the first listed.

NCT02200484 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT02200484's enrollment target sits among peer trials

25 1495th of 2000 higher than 481 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02200484, the US trial registry maintained by the National Library of Medicine. NCT02200484 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.