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NCT01610219 · ClinicalTrials.gov registry record · NA
Lifestyle Modification for Type 2 Diabetes Prevention in Overweight Youth
A NA study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- NA
- Development phase
- 52
- Enrollment target
NCT01610219: Completed NA study, sponsored by University of Pennsylvania.
NCT01610219 is a NA study that has completed, run by University of Pennsylvania. The registered enrollment target is 52 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.
The verdict
NCT01610219, a NA study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- NA
- Development phase
- 52 participants
- Enrollment target
Study Summary
The number of youth with Type 2 diabetes (T2D) is rising in the population, which is a concerning public health trend. There has been little research testing ways to prevent the development of this disease in children who are at increased risk to develop T2D. This study tests a family treatment program that treats 4-8 year old children who are at risk for T2D because they are overweight and have a family history of the disease. Sixty at risk children and their parents were assigned to one of 2 treatment conditions. Half of the families (randomly determined) received an intensive family treatment program that trains parents in how to increase healthier foods choices and physical activity for themselves and their children using "behavior modification" strategies. Children receiving this treatment were allowed to taste new fruits and vegetables used a pedometer to record how far they walked every day, and were given a "tool box" of toys and interactive games which promoted physical activity. The other half of the families only received instruction about healthier choices, but received no behavioral modification strategies or physical activity promotion tools. Improvements in children's body weight, blood measures, and behavior patterns were measured after treatment ended (6 months) and then again after 12 months. The results may lead to a better understanding of how family members can positively influence young children's behaviors to help prevent T2D. The objective of proposed study was to test a family-based intervention designed to reduce excess body weight, improve metabolic and cardiovascular profile, and improve diet and physical activity levels in 4 - 8 year old youth who are "at risk" for T2D. This intervention was tested in a 2-arm randomized controlled clinical trial. Primary Hypotheses: 1. Compared to children receiving NPA, children receiving LMDP will show greater reductions in excess body weight, greater improvements in metabolic and cardiovascular meas
Primary Outcome
Change in BMI will be measured from baseline to end of intervention (6 months) and and also from 6 months to 12 months.
Interventions
- BEHAVIORAL Lifestyle Modification for Type 2 Diabetes Prevention
- OTHER Nutrition and Physical Activity
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2008-08 |
| Est. Completion | 2011-01 |
| Phase | NA |
What the finished NCT01610219 record still lists
NCT01610219 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 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 Lifestyle Modification for Type 2 Diabetes Prevention is the first listed.
NCT01610219 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01610219 about?
NCT01610219 is a clinical study titled "Lifestyle Modification for Type 2 Diabetes Prevention in Overweight Youth". The number of youth with Type 2 diabetes (T2D) is rising in the population, which is a concerning public health trend. There has been little research testing ways to prevent the development of this disease in children who are at increased risk to develop T2D. This study tests a family treatment prog...
What is the current status of trial NCT01610219?
This trial is currently completed. It is a NA study. The enrollment target is 52 participants. The study started on 2008-08. Estimated completion is 2011-01.
What interventions are being tested in trial NCT01610219?
The interventions under investigation include: Lifestyle Modification for Type 2 Diabetes Prevention (BEHAVIORAL), Nutrition and Physical Activity (OTHER).
Who is sponsoring clinical trial NCT01610219?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01610219's enrollment target sits among peer trials
52 1272nd 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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