Overview

This trial has been completed.

Conditions physical activity, dietary modification
Treatment alive
Sponsor University of North Texas Health Science Center
Collaborator M.D. Anderson Cancer Center
Start date November 2014
End date December 2015
Trial size 258 participants
Trial identifier NCT02722850, 001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
PA CONDITION: The goal of the PA condition is to encourage participants to gradually increase moderate to vigorous PA to 150 minutes per week and to increase resistance training to a total of 15 minutes per day twice per week.
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.
(Experimental)
DIET CONDITION: The goal of the dietary condition includes increasing intake of fruit and vegetable to 5-servings per day. The program also encourages participants to increase the consumption of colorful fruits and vegetables. The fat goals consist of reducing saturated fats to <10% of total kilocalories per day, trans fats to <3 grams per day, and added sugar to <50 grams per day.
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.

Primary Outcomes

Measure
Mean metabolic equivalent minutes of physical activity
time frame: 3-months
Diet Quality
time frame: 3-month

Secondary Outcomes

Measure
Mean health related quality of life scores
time frame: 3-months

Eligibility Criteria

Female participants from 18 years up to 80 years old.

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.

Additional Information

Official title A Lifestyle Intervention Via Email (ALIVE) for Cancer Survivors
Principal investigator Raheem Paxton, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by University of North Texas Health Science Center.