NCT02722850

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
258

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2014

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

November 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 30, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

December 1, 2016

Status Verified

November 1, 2016

Enrollment Period

1.1 years

First QC Date

March 20, 2016

Last Update Submit

November 29, 2016

Conditions

Physical ActivityDietary Modification

Keywords

breast cancercancer survivorshipdietary intakephysical activityquality of life

Outcome Measures

Primary Outcomes (2)

  • 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

  • Diet Quality

    Dietary intake was assessed with Block health habits and history questionnaire. This instrument is a validated food frequency questionnaire

    3-month

Secondary Outcomes (1)

  • Mean health related quality of life scores

    3-months

Study Arms (2)

ALIVE - Physical Activity

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.

Behavioral: ALIVE

ALIVE - Dietary Modification

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.

Behavioral: ALIVE

Interventions

ALIVEBEHAVIORAL

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.

ALIVE - Dietary ModificationALIVE - Physical Activity

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Previously diagnosed with breast cancer;
  • years old at time of cancer diagnosis;
  • English-Speaking;
  • Have access to high-speed internet.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 19460655BACKGROUND

  • Paxton RJ, Hajek R, Newcomb P, Dobhal M, Borra S, Taylor WC, Parra-Medina D, Chang S, Courneya KS, Block G, Block T, Jones LA. A Lifestyle Intervention via Email in Minority Breast Cancer Survivors: Randomized Parallel-Group Feasibility Study. JMIR Cancer. 2017 Sep 21;3(2):e13. doi: 10.2196/cancer.7495.

    PMID: 28935620DERIVED

MeSH Terms

Conditions

Motor ActivityBreast Neoplasms

Condition Hierarchy (Ancestors)

BehaviorNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Raheem Paxton, PhD

    UNT - Health Science Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 20, 2016

First Posted

March 30, 2016

Study Start

November 1, 2014

Primary Completion

December 1, 2015

Study Completion

June 1, 2016

Last Updated

December 1, 2016

Record last verified: 2016-11