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NCT00631345 · ClinicalTrials.gov registry record · NA

Healthy Living Partnership to Prevent Diabetes

A NA study, sponsored by Wake Forest University Health Sciences.

Completed
Registry status
NA
Development phase
301
Enrollment target

NCT00631345: Completed NA study, sponsored by Wake Forest University Health Sciences.

NCT00631345 is a NA study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 301 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00631345, a NA study, has completed, sponsored by Wake Forest University Health Sciences.

COMPLETED
Registry status
NA
Development phase
301 participants
Enrollment target

Study Summary

The Healthy Living Partnership to Prevent Diabetes (HELP PD) is a 300-participant randomized trial designed to test the effectiveness of a lay-health counselor led community-based diabetes prevention program in reducing blood glucose in people at risk for developing diabetes mellitus.

Primary Outcome

Change in fasting glucose will be analyzed independently at 12 months (incorporating baseline and 6 month data) and will be used to report the average effect of the intervention during the first year. The analysis at 24 months (incorporating data from baseline, 18 and 24 months) will evaluate the long-term effects of the intervention by examining the average intervention effect during the second year of the intervention period.

Interventions

  • BEHAVIORAL Group-Based Lifestyle Intervention (Phases 1 and 2)
  • OTHER Individual Education Program (All Phases)
  • BEHAVIORAL Self-Directed Maintenance (Phase 3)
  • BEHAVIORAL Extended Group Maintenance (Phase 3)

Trial Details

FieldValue
Enrollment Target 301 participants
Start Date 2007-08
Est. Completion 2015-05
Phase NA
Wake Forest University Health Sciences

1,140 total trials

What the finished NCT00631345 record still lists

NCT00631345 is an interventional study that assigns participants to a tested intervention. The registered 301 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (79% lower).

The record links to 0 conditions, and to 4 interventions - of which Group-Based Lifestyle Intervention (Phases 1 and 2) is the first listed.

NCT00631345 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00631345 about?

NCT00631345 is a clinical study titled "Healthy Living Partnership to Prevent Diabetes". The Healthy Living Partnership to Prevent Diabetes (HELP PD) is a 300-participant randomized trial designed to test the effectiveness of a lay-health counselor led community-based diabetes prevention program in reducing blood glucose in people at risk for developing diabetes mellitus.

What is the current status of trial NCT00631345?

This trial is currently completed. It is a NA study. The enrollment target is 301 participants. The study started on 2007-08. Estimated completion is 2015-05.

What interventions are being tested in trial NCT00631345?

The interventions under investigation include: Group-Based Lifestyle Intervention (Phases 1 and 2) (BEHAVIORAL), Individual Education Program (All Phases) (OTHER), Self-Directed Maintenance (Phase 3) (BEHAVIORAL), Extended Group Maintenance (Phase 3) (BEHAVIORAL).

Who is sponsoring clinical trial NCT00631345?

This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00631345's enrollment target sits among peer trials

301 330th of 2000 higher than 1,671 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 NCT00631345, the US trial registry maintained by the National Library of Medicine. NCT00631345 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.