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Completed Not applicable Interventional Accepts healthy volunteers

DAMES: Daughters And MothErS Against Breast Cancer

ClinicalTrials.gov ID: NCT00630591

Public ClinicalTrials.gov record NCT00630591. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 1, 2026, 10:22 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 the mother-daughter bond, geographic proximity of mothers and daughters, self-efficacy for lifestyle change, etc.

Study identification

NCT ID
NCT00630591
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
Duke University
Other
Enrollment
482 participants

Conditions and interventions

Eligibility (public fields only)

Age range
21 Years and older
Sex
Female
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 31, 2008
Primary completion
Feb 28, 2010
Completion
Jun 30, 2010
Last update posted
Feb 1, 2017

2008 – 2010

United States locations

U.S. sites
2
U.S. states
2
U.S. cities
2
Facility City State ZIP Site status
Duke University Medical Center Durham North Carolina 27708
U.T. M.D. Anderson Cancer Center Houston Texas 77030

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00630591, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 1, 2017 · Synced Sep 1, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00630591 live on ClinicalTrials.gov.

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