Lifestyle, Exercise and Nutrition Study 1 (LEAN)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT02109068
First received: April 4, 2014
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Weight Loss
Behavioral: Weight Loss Counseling- Phone
Behavioral: Weight Loss Counseling- In-Person
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lifestyle, Exercise and Nutrition (LEAN) Study 1

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Change in Body Mass Index (BMI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Change in body weight in kilograms (kg) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Change in percent body fat [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change in fasting insulin [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    All the hormones to be measured (insulin, IGF-1, leptin, adiponectin and C-reactive protein) have been previously measured in our lab and published. Immunoassay techniques and kits from Diagnostic Products Corporation (DPC, Los Angeles, CA) to will be used to measure each hormone value. Each woman's baseline and follow-up samples will be used in the same batch, and an equal number of intervention and control samples will also be included in the same batch. Blind duplicates are also included in and between batches to estimate coefficient of variations.

  • Change in Insulin-like growth factor 1 (IGF-1) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    All the hormones to be measured (insulin, IGF-1, leptin, adiponectin and C-reactive protein) have been previously measured in our lab and published. Immunoassay techniques and kits from Diagnostic Products Corporation (DPC, Los Angeles, CA) to will be used to measure each hormone value. Each woman's baseline and follow-up samples will be used in the same batch, and an equal number of intervention and control samples will also be included in the same batch. Blind duplicates are also included in and between batches to estimate coefficient of variations.

  • Change in Leptin [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    All the hormones to be measured (insulin, IGF-1, leptin, adiponectin and C-reactive protein) have been previously measured in our lab and published. Immunoassay techniques and kits from Diagnostic Products Corporation (DPC, Los Angeles, CA) to will be used to measure each hormone value. Each woman's baseline and follow-up samples will be used in the same batch, and an equal number of intervention and control samples will also be included in the same batch. Blind duplicates are also included in and between batches to estimate coefficient of variations.

  • Change in C-reactive protein [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    All the hormones to be measured (insulin, IGF-1, leptin, adiponectin and C-reactive protein) have been previously measured in our lab and published. Immunoassay techniques and kits from Diagnostic Products Corporation (DPC, Los Angeles, CA) to will be used to measure each hormone value. Each woman's baseline and follow-up samples will be used in the same batch, and an equal number of intervention and control samples will also be included in the same batch. Blind duplicates are also included in and between batches to estimate coefficient of variations.

  • Skin Carotenoids Assessment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Assessment of skin carotenoids will be done using Resonance RAMAN Spectroscopy (RRS). Briefly, a small scanner which shines blue light is placed on the palm of the hand for 30 seconds. The palm is cleaned with an alcohol wipe prior to the scan, A RRS reading is available after a further 30 seconds. The procedure is repeated at the same body location. Skin color is self assessed by the participants at the baseline visit using samples that are used in plastic surgery to assess skin color. Melanin content (skin color) may have a small effect on RRS, but this effect is minimized by assessing skin carotenoids in the palm, which has a lower melanin content than other body sites.

  • Maintenance of Weight Loss [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    A mailed follow up will be conducted at 12-months post randomization. Questionnaires will be mailed to the participant with a pre-paid envelope for their return. Information about current weight will be conducted using this method.


Other Outcome Measures:
  • Change in Physical Activity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The 7-Day Daily Activity Log (7-Day DAL) will be the primary measure used to compare physical activity levels at baseline and 6-months among the three groups. All participants will complete the log for seven consecutive days, recording the amount of time spent in moderate- to vigorous-intensity recreational exercise. Total minutes per week of exercise will be calculated. Participants randomized to in-person and telephone counseling will also complete the 7-day DAL weekly.

  • Change in Dietary Intake [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The endpoint measures of diet change will be mean, group level changes in daily caloric intake, based on a 120-item food frequency questionnaire (FFQ) which was developed for the Women's Health Initiative Study and has been validated against 4-Day Food Records and 24-hour Dietary Recalls. FFQs will be administered at baseline and 6-months.


Enrollment: 100
Study Start Date: January 2011
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: In-Person Counseling
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

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.

Active Comparator: Telephone-based Counseling
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

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.

No Intervention: Usual Care
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.

Detailed Description:

Proposed is a three-arm randomized controlled trial of 6-months of weight loss counseling (i.e., dietary-induced caloric restriction and physical activity) on clinically meaningful endpoints in 100 breast cancer survivors . The three arms will be: 1. In-person counseling, 2. Telephone-based counseling, 3. Usual care. Women will be randomized into one of 3 study arms using a random permuted block design. Research staff collecting body composition data, as well as reviewing forms and entering data, will be blinded to the participant's study group.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02109068

Locations
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Melinda L Irwin, PhD, MPH Yale University
  More Information

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02109068     History of Changes
Other Study ID Numbers: 1012007780
Study First Received: April 4, 2014
Last Updated: April 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Breast Cancer
Survivorship
Weight Loss

Additional relevant MeSH terms:
Breast Neoplasms
Weight Loss
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 21, 2014