Exergaming Intervention and Breast Cancer Biomarkers in Black Women

NCT02152462 | Completed Phase 2

• 1 other identifier: Pro00000116 Georgetown Lombard
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Overview: This is a 6 month, two-arm randomized clinical trial using comparing exergaming to a control group. The investigators will randomize Black sedentary overweight/obese women to Wii Fit exercise (n=50) or the control arm (n=50). Women in the Wii Fit exercise group will come to the Georgetown community-based exercise facility 3 days/wk. The control group will be asked to maintain their current daily activities and not to exercise for the duration of the study. Based on the investigators previous findings that women who engage in 75-150 mins/wk of brisk walking had an 18% decreased risk of breast cancer, the investigators will target this level of activity in the investigators intervention arm. Also, this 150 min/week of physical activity meets the current recommendations of the American College of Sports Medicine (ACSM) and the US Department of Health and Human Services for healthy individuals and is in line with recommendation of the American Cancer Society (ACS) for cancer prevention.

Conditions

Breast Cancer; Obesity

Keywords

exergaming; breast cancer; African American women; obesity

Outcome Measures

Primary Outcomes (1)

• Biomarkers related to obesity and breast cancer risk

  Outcomes for plasma leptin, adiponectin, Insulin-like growth factor 1 (IGF-1), Insulin-like growth factor-binding protein 3 (IGFBP3), C-reactive protein (CRP), Interleukin 6 (IL-6), insulin, c-peptide, and Hb-A1c levels at baseline and 24 weeks.

  6 months

Secondary Outcomes (2)

• Cardiovascular fitness (VO2 max)

  6 months

• Reported stress levels

  6 months

Study Arms (2)

Exergaming

OTHER

Exercise Intervention: Participants in the Wii Fit exergaming group will have a goal of 150 min/wk of moderate intensity exercise for the last 5 mo of the 6 mo intervention. Heart rate (HR) monitors will quantify exercise intensity. Participants will exercise at a HR equal to 45-65% of their VO2max. Participants will be instructed by the exercise physiologist on how to achieve the required HR. The training will consist of 3 days/wk of supervised Wii Fit physical activity. Exercise duration will increase gradually from 75 to 150 min/wk by wk 477. Thereafter, women will maintain \>150 min/wk of moderate-intensity physical activity. Participants will complete daily exercise diaries recording the type and duration of physical activity, and HR.

Other: Exergaming

Control

NO INTERVENTION

Control Group: After baseline testing the control group will be asked to maintain their current daily activities for the duration of the study. The control group will have the option to exercise at the Wii Fit stations following their completion of the study. They will receive the same measures as the exercise group.

Interventions

Exergaming OTHER

The participants in the Wii Fit exergaming group will be encouraged to meet and then maintain a goal of 150 min/wk of moderate intensity exercise for 6 months. Goals per individual will be based on their baseline data. Exercise duration will increase gradually from 75 min/wk at week 1 to 150 min/wk by week 4. Thereafter, women will maintain \>150 min/wk of moderate-intensity physical activity. The training will consist of 3 days/wk of supervised physical activity using Nintendo Wii Fit active videogames.

Exergaming

Eligibility Criteria

• Age: 40 Years - 59 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Black women
• BMI ≥28 kg/m2 but ≤ 350 pounds of body weight
• Aged 40-59 years
• Sedentary (\<60 min/wk exercise for past 6 months
• Never been diagnosed with cancer
• Ability to read and speak English and to provide meaningful consent
• No physical limitations preventing them from exercising
• Medical clearance by a health practitioner.

You may not qualify if:

• History of cancer
• Uncontrolled hypertension and medically treated diabetes
• Current enrollment in another physical activity and/or dietary study or a diet/weight loss program
• Pregnancy
• Inability to consent to study participation and complete assessments
• Telephone inaccessibility
• Physical limitations to exercise inability to commit to the intervention schedule

Sponsors & Collaborators

• Georgetown University: lead

Study Sites (1)

Georgetown Lombardi Office of Minority Health & Health Disparities Research

Washington D.C., District of Columbia, 20003, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Obesity

Interventions

Exergaming

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Lucile L Adams-Campbell, PhD

  Georgetown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 31, 2014
• First Posted: June 2, 2014
• Study Start: December 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: December 1, 2019
• Last Updated: February 10, 2020

Record last verified: 2020-02

Locations

US (1)