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NCT01662557 · ClinicalTrials.gov registry record · NA

Treatment of Early Childhood Overweight in Primary Care: Pilot Study

A NA study, sponsored by University of Pennsylvania.

Completed
Registry status
NA
Development phase
51
Enrollment target

NCT01662557: Completed NA study, sponsored by University of Pennsylvania.

NCT01662557 is a NA study that has completed, run by University of Pennsylvania. The registered enrollment target is 51 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01662557, a NA study, has completed, sponsored by University of Pennsylvania.

COMPLETED
Registry status
NA
Development phase
51 participants
Enrollment target

Study Summary

Childhood overweight continues to increase at an alarming rate and the need exists to find effective, accessible intervention strategies to prevent and treat children who are at risk for being overweight or are already overweight. The primary care setting provides an attractive option for families wishing to receive treatment, yet little is known about the feasibility, acceptance or efficacy of this intervention setting. The purpose of this study was to test two different primary care treatments that were intended to increase fruit and vegetable intake, increase physical activity, and reduce sedentary activity in children ages 4-8, who are overweight or at risk for becoming overweight. Both treatments involved the child and a parent/caregiver and both were conducted over a four month period. The parent/child dyads were selected from the pool of families who receive their primary care within the Geisinger Medical Center geographic area and who have been identified by their pediatrician as being overweight or at risk for becoming overweight (BMI \>85th percentile for age). One group received weekly mailings which focused on healthy eating, promotion of fruit and vegetable intake and physical activity, and methods to reduce TV viewing time. The second group received a group-based intervention at one of the Geisinger Pediatric Clinic sites using specific behavioral strategies for increasing fruit and vegetable intake, reducing TV viewing and encouraging physical activity. Changes in overweight percentage, child BMI, lipid profile, glucose/insulin levels, and anthropometric measurements were analyzed, as well as treatment satisfaction and acceptance. The investigators hypothesized that children who receive Family Behavior Modification (FBM) in the primary care setting will show greater reductions in Body Mass Index (BMI), BMI z-score, percent overweight and waist circumference, and that children receiving FBM will show greater improvements in dietary intake, increased ph

Primary Outcome

Change in child's overweight percentage will be measured from baseline to end of treatment (month 5)

Interventions

  • BEHAVIORAL Family Behavior Modification
  • OTHER Minimal Nutrition Information

Trial Details

FieldValue
Enrollment Target 51 participants
Start Date 2008-02
Est. Completion 2011-03
Phase NA
University of Pennsylvania

1,423 total trials

What the finished NCT01662557 record still lists

NCT01662557 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 2 interventions - of which Family Behavior Modification is the first listed.

NCT01662557 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01662557 about?

NCT01662557 is a clinical study titled "Treatment of Early Childhood Overweight in Primary Care: Pilot Study". Childhood overweight continues to increase at an alarming rate and the need exists to find effective, accessible intervention strategies to prevent and treat children who are at risk for being overweight or are already overweight. The primary care setting provides an attractive option for families w...

What is the current status of trial NCT01662557?

This trial is currently completed. It is a NA study. The enrollment target is 51 participants. The study started on 2008-02. Estimated completion is 2011-03.

What interventions are being tested in trial NCT01662557?

The interventions under investigation include: Family Behavior Modification (BEHAVIORAL), Minimal Nutrition Information (OTHER).

Who is sponsoring clinical trial NCT01662557?

This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01662557's enrollment target sits among peer trials

51 1279th of 2000 higher than 722 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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 NCT01662557, the US trial registry maintained by the National Library of Medicine. NCT01662557 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.