NCT02681965

Brief Summary

Proposed is a 6-month randomized controlled trial, in 200 overweight or obese Stage I-IIIC breast cancer survivors examining 6-month changes in: 1) body weight, 2) diet, 3) physical activity, and 4)quality of life in women randomized to receive the modified LEAN intervention compared to women randomized to wait-list control (i.e., the wait-list control will receive the modified LEAN intervention after completing the 6-month study).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
205

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 10, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 15, 2016

Completed
15 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

June 29, 2018

Status Verified

June 1, 2018

Enrollment Period

2.1 years

First QC Date

February 10, 2016

Last Update Submit

June 28, 2018

Conditions

Breast Cancer SurvivorshipObesity

Outcome Measures

Primary Outcomes (1)

  • Body weight (kg)

    A standard digital scale will be mailed to each participant along with the baseline packet to allow consistent measurement of weight by participants. Participants will weigh themselves. Body weight will be collected in kilograms (kg).

    6 Months

Secondary Outcomes (13)

  • Body weight (kg)

    Baseline

  • Body weight (kg)

    12 Months

  • Quality of Life (QOL)

    Baseline

  • Quality of Life (QOL)

    6 months

  • Dietary Intake

    Baseline

  • +8 more secondary outcomes

Study Arms (2)

LEAN

EXPERIMENTAL

Participants randomized to the weight loss program will initially receive the LEAN book, as well as a CD and flash drive with the LEAN videos (and internet link), a pedometer and the Log Book for recording their food intake and physical activity. Written instructions in the LEAN book will include recording daily diet and exercise in the logs. At the end of the study, participants will return, via a stamped addressed envelope, the logs to the study office so compliance can be assessed.

Behavioral: LEAN book/videos

Waitlist Control

NO INTERVENTION

Participants randomized to the waitlist control study arm will be mailed the six-month questionnaires, which will include reporting of weight. On return of the 6-month questionnaires each woman will be provided with the entire weight loss program packet.

Interventions

LEAN book/videosBEHAVIORAL

The intervention focuses on achieving long lasting lifestyle changes to achieve weight loss and maintenance. Women randomized to the weight loss program will receive the LEAN book, as well as a CD and flash drive with the LEAN videos (and internet link), a pedometer and the Log Book for recording their food intake and physical activity.

LEAN

Eligibility Criteria

Age18 Years - 79 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Overweight individuals (BMI \>= 25.0 kg/m2)
  • Breast cancer survivors who have completed chemotherapy and/or radiation therapy
  • Stage 0-III
  • The ability to be physically able to exercise (e.g. walk at a moderate pace)
  • Agree to random assignment to either group
  • Give informed consent to participate in all study activities
  • Accessible by telephone
  • Able read and communicate in English

You may not qualify if:

  • Pregnant or intending to become pregnant in the next year
  • Recent (past 6 months) stroke or myocardial infarction
  • Severe uncontrolled mental illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yale School of Medicine Irwin, Ph.D.

    MEPH Chronic Diseases, Yale School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2016

First Posted

February 15, 2016

Study Start

March 1, 2016

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

June 29, 2018

Record last verified: 2018-06

Locations

US(1)