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NCT00630591 · ClinicalTrials.gov registry record · NA
DAMES: Daughters And MothErS Against Breast Cancer
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 482
- Enrollment target
NCT00630591 is a NA study that has completed, run by Duke University. The registered enrollment target is 482 participants.
The verdict
NCT00630591, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 482 participants
- Enrollment target
Study Summary
Primary Aim: -To explore the feasibility and acceptability of two distinctly different tailored, home-based diet and exercise interventions (one that relies on a partner-assisted, team-based approach that emphasizes the mother-daughter bond and one that is delivered to each independently) vs. standardized materials (attention control). This aim will be accomplished by assessing overall accrual, and by quantifying retention and adverse events in each study arm. The study will be deemed feasible if it achieves the following criteria: 1. Accrual of 67 mother-daughter dyads into the intervention is accomplished within a 1-year period; 2. An attrition rate of less than 20% is achieved; and 3. The frequency of total adverse events is not significantly higher in either of the intervention arms (as compared to the attention control arm), and there is no more than one reported serious adverse event that is directly attributable to either of the interventions. Detailed process data also will be collected on each intervention, i.e., use and perceived helpfulness of materials in promoting behavior change, frequency and quality of interaction between members of the mother-daughter dyad, feedback regarding intervention materials, etc. Secondary Aim: -To explore potential effects (and variation) noted among each of the three intervention arms from baseline to 6 and 12- month follow-up on the following endpoints: BMI, energy intake and nutrient density of the diet, exercise \[min/week and metabolic equivalents (METs)\], self-efficacy to adhere to an energy restricted, plant-based, low saturated fat diet and increased exercise, blood pressure, health-related quality of life (HRQOL), social support (in general and as specifically related to healthful dietary and exercise behavior), and characteristics of the mother-daughter bond (e.g., strength). Secondary Aim: -To explore potential mediators and moderators of healthful dietary and exercise behaviors, such as the strength of
Interventions
- BEHAVIORAL Standardized Materials Group
- BEHAVIORAL Independent Tailored Intervention
- BEHAVIORAL Partner-Assisted Tailored Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 482 participants |
| Start Date | 2008-02 |
| Est. Completion | 2010-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00630591
The ClinicalTrials.gov registry entry for NCT00630591 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 482 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Standardized Materials Group is the first listed.
NCT00630591 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00630591 about?
NCT00630591 is a clinical study titled "DAMES: Daughters And MothErS Against Breast Cancer". Primary Aim: -To explore the feasibility and acceptability of two distinctly different tailored, home-based diet and exercise interventions (one that relies on a partner-assisted, team-based approach that emphasizes the mother-daughter bond and one that is delivered to each independently) vs. stand...
What is the current status of trial NCT00630591?
This trial is currently completed. It is a NA study. The enrollment target is 482 participants. The study started on 2008-02. Estimated completion is 2010-07.
What interventions are being tested in trial NCT00630591?
The interventions under investigation include: Standardized Materials Group (BEHAVIORAL), Independent Tailored Intervention (BEHAVIORAL), Partner-Assisted Tailored Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT00630591?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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