Physical ActivityNCT02722850
Web-based Study for Cancer Survivors
A study testing ALIVE in people with Physical Activity and Dietary Modification, run by University of North Texas Health Science Center.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Physical Activity, Dietary Modification
- What is being tested?
- ALIVE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previously diagnosed with breast cancer;
- 18-80 years old at time of cancer diagnosis;
- English-Speaking;
- Have access to high-speed internet.
Who cannot join
- 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.
About this study
Official title: A Lifestyle Intervention Via Email (ALIVE) for Cancer Survivors
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.
Read the detailed 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.
- Conditions
- Physical Activity, Dietary Modification
- Being tested
- ALIVE
- Keywords
- breast cancer, cancer survivorship, dietary intake, physical activity, quality of life
- Medical subject headings
- Motor Activity, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALIVEBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: ALIVE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3-months
Diet Quality
Dietary intake was assessed with Block health habits and history questionnaire. This instrument is a validated food frequency questionnaire
Measured: 3-month
Secondary outcomes (1)
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.
Measured: 3-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2016 (estimated)
- Study startNov 2014
- Primary completionDec 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Texas Health Science Center
- Sponsor type
- University, hospital or other
- Collaborators
- M.D. Anderson Cancer Center, The University of Texas Health Science Center, Houston, University of Houston, University of Alberta
- Responsible party
- Principal investigator, Raheem Paxton, University of North Texas Health Science Center
- Investigators
- Raheem Paxton, PhD, Principal investigator, UNT - Health Science Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02722850
- Sponsor's protocol ID
- 001
- Status last verified
- Nov 2016
- First submitted
- 20 Mar 2016
- Last updated
- 1 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: Once data are compiled, the investigators will decide whether it will be available for sharing
Publications
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.
PubMed 19460655Paxton 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.
PubMed 28935620
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Lifestyle Intervention Via Email (ALIVE) for Cancer Survivors
- ClinicalTrials.gov ID
- NCT02722850
- Acronym / sponsor ID
- 001
- Conditions
- Physical Activity, Dietary Modification
- Keywords
- breast cancer, cancer survivorship, dietary intake, physical activity, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- University of North Texas Health Science CenterUniversity, hospital or other
- Collaborators
- M.D. Anderson Cancer Center, The University of Texas Health Science Center, Houston, University of Houston, University of Alberta
- Study start
- Nov 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 30 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALIVE - Physical Activity | Experimental | Behavioral: ALIVEPA 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 - Dietary Modification | Experimental | Behavioral: ALIVEDIET 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Previously diagnosed with breast cancer;
- 18-80 years old at time of cancer diagnosis;
- English-Speaking;
- Have access to high-speed internet.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALIVEALIVE 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. | Behavioural | ALIVE - Dietary Modification, ALIVE - Physical Activity |
Primary outcome
Mean metabolic equivalent minutes of physical activity
Time frame: 3-months
Physical activity and sedentary behavior were assessed with the Work and Home Activity Questionnaire at baseline and at 3-months
Diet Quality
Time frame: 3-month
Dietary intake was assessed with Block health habits and history questionnaire. This instrument is a validated food frequency questionnaire
1 secondary outcome
Mean health related quality of life scores
Time frame: 3-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2016.
- Background: PubMed 19460655Sternfeld 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.
- Derived from this study: PubMed 28935620Paxton 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.
- Individual participant dataSharing planned: Undecided. Once data are compiled, the investigators will decide whether it will be available for sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raheem Paxton, PhD principal investigator
UNT - Health Science Center
Questions about this trial
What is this clinical trial studying?
A study testing ALIVE in people with Physical Activity and Dietary Modification, run by University of North Texas Health Science Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean metabolic equivalent minutes of physical activity (time frame: 3-months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02722850, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2016.