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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02722850
Other study ID # 001
Secondary ID
Status Completed
Phase N/A
First received March 20, 2016
Last updated November 29, 2016
Start date November 2014
Est. completion date June 2016

Study information

Verified date November 2016
Source University of North Texas Health Science Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

In this parallel group study, participants were randomized to either 1 of 3 conditions (a) fruit and vegetable consumption, (b) dietary fat and added sugars, or (c) physical activity.


Description:

In this study, the investigators will evaluate the feasibility and preliminary results of a 3-month web-based lifestyle intervention 500 female cancer survivors.

Specific aim 1: to determine the rates of recruitment, retention, attendance, satisfaction, adverse events, and barriers to participation in the proposed intervention.

Specific aim 2: to determine whether a home-based intervention is associated with greater improvements in mean minutes of moderate to vigorous physical activity, diet quality, body size, constructs of Social Cognitive Theory, and health-related quality of life than participants randomized to a sedentary behavior reduction condition.


Recruitment information / eligibility

Status Completed
Enrollment 258
Est. completion date June 2016
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Previously diagnosed with breast cancer;

- 18-80 years old at time of cancer diagnosis;

- English-Speaking;

- Have access to high-speed internet.

Exclusion Criteria:

- Be currently enrolled in another intervention study or recently completed a study promoting healthy lifestyle behaviors (diet and/or exercise).

- Participants answering 'Yes' to one or more of the questions on the physical activity readiness questionnaire (PAR-Q) will need to obtain approval from a physician before they can participate in the intervention.

- Pregnant women will be excluded from the protocol.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Behavioral:
ALIVE
ALIVE is an email-based platform designed to help participants increase their physical activity, increase fruit and vegetable consumption, and decrease their intake of saturated and trans fats and added sugars. This automated system contains content and tailoring that is delivered in the form of emails obtained directly from cancer patients. Additional information they will receive included: tips for achieving those goals, health information, and opportunities for interaction and engagement.

Locations

Country Name City State
n/a

Sponsors (5)

Lead Sponsor Collaborator
University of North Texas Health Science Center M.D. Anderson Cancer Center, The University of Texas Health Science Center, Houston, University of Alberta, University of Houston

References & Publications (1)

Sternfeld B, Block C, Quesenberry CP Jr, Block TJ, Husson G, Norris JC, Nelson M, Block G. Improving diet and physical activity with ALIVE: a worksite randomized trial. Am J Prev Med. 2009 Jun;36(6):475-83. doi: 10.1016/j.amepre.2009.01.036. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Mean metabolic equivalent minutes of physical activity Physical activity and sedentary behavior were assessed with the Work and Home Activity Questionnaire at baseline and at 3-months 3-months No
Primary Diet Quality Dietary intake was assessed with Block health habits and history questionnaire. This instrument is a validated food frequency questionnaire 3-month No
Secondary Mean health related quality of life scores Health-related quality of life will be assessed with instruments measuring functional status, pain and fatigue interference, and cognitive function at baseline and at 3-months. 3-months No
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