NCT01559194

Brief Summary

The primary specific aim of this study was to determine if overweight and obese premenopausal women can lose weight and if long term weight loss impacts biomarkers associated with breast cancer risk.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at below P25 for phase_3 breast-cancer

Timeline
Completed

Started May 2005

Shorter than P25 for phase_3 breast-cancer

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 21, 2012

Completed
Last Updated

April 14, 2014

Status Verified

April 1, 2014

Enrollment Period

2.6 years

First QC Date

March 19, 2012

Last Update Submit

April 10, 2014

Conditions

Breast CancerWeight Loss

Outcome Measures

Primary Outcomes (1)

  • Number of women who lose weight when following 1 of 2 different calorie-restricted diets

    18 months

Secondary Outcomes (1)

  • Number of women that long-term weight loss impacted biomarkers (including Insulin-like growth factor (IGF)- 1 and IGFBP-3) associated with breast cancer risk

    12 months

Study Arms (2)

Low Fat Diet + Exercise

ACTIVE COMPARATOR

Subjects were educated about a low fat diet plus exercise and then followed for weight loss. They were also asked to monitor their physical activity by wearing a pedometer and recording the total steps walked every day.

Behavioral: Low Fat Diet plus exercise

Low Carbohydrate Diet + Exercise

ACTIVE COMPARATOR

Subjects were educated about a low carbohydrate diet plus exercise and then followed for weight loss. They were also asked to monitor their physical activity by wearing a pedometer and recording the total steps walked every day.

Behavioral: Low Carbohydrate diet + Exercise

Interventions

Low Fat Diet plus exerciseBEHAVIORAL

Low fat diet plus exercise - Subjects were educated about a low fat diet plus exercise and then followed for weight loss. They were also asked to monitor their physical activity by wearing a pedometer and recording the total steps walked every day.

Low Fat Diet + Exercise
Low Carbohydrate diet + ExerciseBEHAVIORAL

Low carbohydrate diet plus exercise: Subjects were educated about a low carbohydrate diet and then followed for weight loss. They were also asked to monitor their physical activity by wearing a pedometer and recording the total steps walked every day.

Low Carbohydrate Diet + Exercise

Eligibility Criteria

Age30 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 30 and older
  • Premenopausal (may be confirmed by FSH)
  • No previous diagnosis of cancer (except non-melanomatous skin cancer)
  • Body mass index between 25-34 kg/m2
  • Women must be expected to live in the Columbus area for the next 18 months.
  • All women must present a letter of medical clearance from their primary care physician.

You may not qualify if:

  • Pregnant women or women who plan to become pregnant during the study period will not be enrolled. Women who become pregnant during the intervention will be withdrawn from the study.
  • Women who are already participating in a formal weight loss program (such as Weight Watchers)will not be eligible.
  • Women with a medical history that precludes adherence to either of the two dietary patterns will also be excluded. This includes a history of renal insufficiency, gluten enteropathy, Crohn's disease or other medical conditions that significantly impact nutritional status or metabolism. Women with either type I or controlled type II diabetes will be eligible to participate in this trial.
  • All medical problems must be managed and controlled. Lipid profile, blood glucose, hemoglobin A1c, and blood pressure will be assessed at the screening visit. These results will be reviewed by the study physician. Women who have abnormal values that, at the discretion of the study physician, would benefit from medical management will be referred to a primary care physician prior to considering them for enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University

Columbus, Ohio, 43201, United States

Location

Related Publications (4)

  • David P, Buckworth J, Pennell ML, Katz ML, DeGraffinreid CR, Paskett ED. A walking intervention for postmenopausal women using mobile phones and Interactive Voice Response. J Telemed Telecare. 2012 Jan;18(1):20-5. doi: 10.1258/jtt.2011.110311. Epub 2011 Nov 3.

    PMID: 22052963RESULT

  • Llanos AA, Krok JL, Peng J, Pennell ML, Vitolins MZ, Degraffinreid CR, Paskett ED. Effects of a walking intervention using mobile technology and interactive voice response on serum adipokines among postmenopausal women at increased breast cancer risk. Horm Cancer. 2014 Apr;5(2):98-103. doi: 10.1007/s12672-013-0168-4. Epub 2014 Jan 17.

    PMID: 24435584RESULT

  • Foraker RE, Pennell M, Sprangers P, Vitolins MZ, DeGraffinreid C, Paskett ED. Effect of a low-fat or low-carbohydrate weight-loss diet on markers of cardiovascular risk among premenopausal women: a randomized trial. J Womens Health (Larchmt). 2014 Aug;23(8):675-80. doi: 10.1089/jwh.2013.4638. Epub 2014 Jul 16.

    PMID: 25029619DERIVED

  • Llanos AA, Krok JL, Peng J, Pennell ML, Olivo-Marston S, Vitolins MZ, Degraffinreid CR, Paskett ED. Favorable effects of low-fat and low-carbohydrate dietary patterns on serum leptin, but not adiponectin, among overweight and obese premenopausal women: a randomized trial. Springerplus. 2014 Apr 4;3:175. doi: 10.1186/2193-1801-3-175. eCollection 2014.

    PMID: 24790820DERIVED

Related Links

MeSH Terms

Conditions

Breast NeoplasmsWeight Loss

Interventions

Diet, Fat-RestrictedExerciseDiet, Carbohydrate-Restricted

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Electra D. Paskett, PhD

    The Ohio State University Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Director for Population Sciences, Comprehensive Cancer Center, Ohio State University; Marion N. Rowley Professor of Cancer Research and Director, Division of Cancer Prevention and Control

Study Record Dates

First Submitted

March 19, 2012

First Posted

March 21, 2012

Study Start

May 1, 2005

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

April 14, 2014

Record last verified: 2014-04

Locations

US(1)