Brief Summary

This trial studies how well weight management and health behavior intervention works in helping patients with hereditary breast and ovarian cancer and Lynch syndrome mutation carriers lose or maintain a healthy weight and lower their risk for cancer. Lifestyle behaviors such as physical activity, diet, and weight management may play a key role in preventing cancers and improving outcomes even in those with hereditary cancer syndromes.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

384

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach

1 country

1 active site

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

9.3 years study duration

Study Start

First participant enrolled

January 26, 2017

Completed

2.3 years until next milestone

First Submitted

Initial submission to the registry

May 6, 2019

Completed

5 months until next milestone

First Posted

Study publicly available on registry

October 14, 2019

Completed

6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed

Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

9.3 years

First QC Date

May 6, 2019

Last Update Submit

April 13, 2026

Conditions

Hereditary Breast Carcinoma Hereditary Ovarian Carcinoma Lynch Syndrome

Outcome Measures

Primary Outcomes (1)

Percent weight loss
The data from the proposed factorial experiment will be analyzed through analysis of variance (ANOVA) with repeated measures. The outcome variable is the percent weight loss of each participant at 4 months. The fixed covariates include indicator variables for all intervention components. The model includes a random intercept that introduces within-family correlation. The main effect of each intervention component will be tested in an F-test at alpha = 0.0125 level. The pairwise interactions of the intervention components will be studied in an exploratory fashion. The optimal intervention is defined to be the combination of the four components that produces the best percent weight loss result within the resource constraints. Data can also be analyzed jointly in a linear mixed model that includes intervention components and time as fixed effect, family as random intercept and longitudinal correlation between 4 and 8 month data.
Baseline to 4 months

Secondary Outcomes (3)

Fruit and vegetable consumption
Up to 8 months
Percent energy from fat
Up to 8 months
Physical activity
Up to 8 months

Study Arms (1)

Prevention (weight management, health behavior intervention)

EXPERIMENTAL

Participants undergo weight management and health behavior intervention with a combination of 4 components for 16 weeks. TELEPHONE COACHING: Participants receive 1 phone call each week from a coach over 30-45 minutes to discuss diet, physical activity and goal setting. EMAIL COACHING: Participants receive 1 phone call to discuss the process over 10-15 minutes and then receive 1 email each week for 16 weeks. NO COACHING: Participants receive 1 phone call the first week over 10-15 minutes to discuss the process. TEXT MESSAGING: Participants receive 7-12 text messages comprising information about diet and physical activity each week for 16 weeks. SELF-MONITORING: Participants record their food intake and weight directly into the Fitbit website or application 4-7 days each week or 1 day each week for 16 weeks. FAMILY TEAM INTERVENTION: Participants receive 2 group phone calls and join a Facebook group that is monitored by research staff where they can interact with each other and coaches.

Behavioral: Behavioral Dietary InterventionOther: E-mailBehavioral: Exercise InterventionOther: Health Promotion and EducationOther: Internet-Based InterventionOther: Questionnaire AdministrationBehavioral: Telephone-Based Intervention