Lifestyle, Exercise and Nutrition Study 1

NCT02109068 | Completed Phase 3 DMC

• 1 other identifier: 1012007780
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The specific aims of this study are to determine the efficacy and cost-effectiveness of a weight loss program compared with usual care (control) treatment on 6-month changes in body weight, body fat, and serum hormones in breast cancer survivors.

Conditions

Breast Cancer; Weight Loss

Keywords

Breast Cancer; Survivorship; Weight Loss

Outcome Measures

Primary Outcomes (3)

• Change in Body Mass Index (BMI)

  BMI will be calculated using weight and height measurements (weight (kg)/height (m)\^2 ). Weight and height will be measured by research staff blinded to the participant's randomization group at baseline and 6-months. Participants will be weighed in light indoor clothing, without shoes, rounding up to the nearest 0.1 kg; height will be measured in a standard manner, without shoes, using a stadiometer, rounding up to the nearest 0.1 cm. All measures will be performed and recorded twice in succession.

  6 months

• Change in body weight in kilograms (kg)

  Participants will be weighed in light indoor clothing, without shoes, rounding up to the nearest 0.1 kg. All measures will be performed and recorded twice in succession.

  6 months

• Change in percent body fat

  Dual Energy X-Ray Absorptiometry (DEXA) scans will be performed at baseline and 6-months. The DEXA measurements will be made with a Hologic scanner (Hologic 4500 with a "Discovery" upgrade, Hologic Inc, Waltham, Mass). A whole-body scan takes approximately 10 minutes to complete. Percent body fat will be measured utilizing DEXA.

  6 months

Secondary Outcomes (6)

• Change in fasting insulin

  6 months

• Change in Insulin-like growth factor 1 (IGF-1)

  6 months

• Change in Leptin

  6 months

• Change in C-reactive protein

  6 months

• Skin Carotenoids Assessment

  6 months

Other Outcomes (2)

• Change in Physical Activity

  6 months

• Change in Dietary Intake

  6 months

Study Arms (3)

In-Person Counseling

ACTIVE COMPARATOR

Participants randomized to in-person counseling will meet via in-person or via telephone (but at least 3 of the 11 sessions must be in person) weekly for month 1, then every other week for months 2, and 3, and then monthly for months 4-6 at Yale University. The meetings will last 30 minutes. Participants will turn in their diet and exercise logs and also be weighed. A lesson will then be discussed (see above for content).

Behavioral: Weight Loss Counseling- In-Person

Telephone-based Counseling

ACTIVE COMPARATOR

The exact same information, content, schedule, and 30 minute sessions will be provided to telephone-based participants as offered to participants who receive in-person counseling. Participants will be taught diet, exercise and behavior change strategies via the telephone (weekly calls for month 1, every other week for months 2-3, and monthly for months 4-6). All lessons and diet and physical activity logs will be mailed to them at the beginning of the program. Participants will record their daily diet and exercise in the logs. Every four weeks, participants will return, via stamped, addressed envelopes, the logs to the study office.

Behavioral: Weight Loss Counseling- Phone

Usual Care

NO INTERVENTION

Immediately after randomization, participants in the Usual Care Group will be provided written information that emphasizes the importance of a healthy lifestyle. Usual care participants will be encouraged to follow the American Cancer Society (ACS) nutrition and physical activity guidelines. Upon completion of the study (at 6 months), usual care participants will be offered all the educational material, as well as an in-person or telephone counseling session.

Interventions

Weight Loss Counseling- Phone BEHAVIORAL

The intervention will be based on the Diabetes Prevention Program weight loss program, which uses a combination of reduced caloric intake, increased physical activity, and behavior therapy. The content of the weight loss program will be similar for the in-person and telephone interventions, but the approach will vary (i.e., in-person vs. telephone counseling). The weight loss intervention will be conducted by a Registered Dietitian, who has training in exercise physiology and behavior modification. During the 6-month intervention, participants will receive weekly (month 1), then bi-weekly (months 2 and 3), then monthly (months 4, 5, and 6) individualized counseling sessions. An advantage of tapering the frequency of visits from weekly to every other week and then monthly works as a process tool to help transfer the work or responsibility onto the participant for life long change and maintenance of behavior change.

Telephone-based Counseling

Weight Loss Counseling- In-Person BEHAVIORAL

The intervention will be based on the Diabetes Prevention Program weight loss program, which uses a combination of reduced caloric intake, increased physical activity, and behavior therapy. The content of the weight loss program will be similar for the in-person and telephone interventions, but the approach will vary (i.e., in-person vs. telephone counseling). The weight loss intervention will be conducted by a Registered Dietitian, who has training in exercise physiology and behavior modification. During the 6-month intervention, participants will receive weekly (month 1), then bi-weekly (months 2 and 3), then monthly (months 4, 5, and 6) individualized counseling sessions. An advantage of tapering the frequency of visits from weekly to every other week and then monthly works as a process tool to help transfer the work or responsibility onto the participant for life long change and maintenance of behavior change.

In-Person Counseling

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Joint Committee on Cancer (AJCC) Stages 0-IIIC Breast Cancer
• BMI \>25 kg/m2
• Completed surgery, chemotherapy and radiation at least 2 months ago
• Physically able to exercise
• Agrees to be randomly assigned to either weight loss or control
• Gives informed consent to participate in all study activities
• Able to come for baseline and 6-month clinic visits
• Mentally competent

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale University

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Weight Loss

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Melinda L Irwin, PhD, MPH

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2014
• First Posted: April 9, 2014
• Study Start: January 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: April 9, 2014

Record last verified: 2014-04

Locations

US (1)