Weight LossNCT02871388
Addressing Modifiable Breast Cancer Risk Factors With Project CONECT
A study testing CONECT in people with Weight Loss and Breast Cancer Risk Factors, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The objective of this protocol is to adapt and pilot test an existing lifestyle modification intervention for weight loss for women with overweight or obesity who have had a recent false positive mammography screen. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Weight Loss, Breast Cancer Risk Factors
- What is being tested?
- CONECT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2017to 28 Feb 2019
- 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 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female
- 40-65 years of age,
- Received a negative mammography screening result in the previous four weeks
- Moderately sedentary lifestyle (less than 120 minutes/week moderate intensity activity),
- Answer "no" to all questions on the Physical Activity Readiness Questionnaire (PAR-Q).
- BMI 25-40 kg/m2
- Has access to a computer or mobile device with wireless internet
- Able to speak and read English (language requirements are necessary because we cannot accommodate additional languages in prototype development phase.)
Who cannot join
- Previous history or current diagnosis of breast cancer
- Pregnancy or lactation
- Involvement in a weight loss program
- Major co-morbidities (e.g.,diabetes, hypertension, etc.)
- History of disordered eating
- Currently taking medication that may impact weight (e.g., synthroid, metformin)
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298
About this study
Official title: Addressing Modifiable Breast Cancer Risk Factors With Project CONECT [Connect Online to Engage Change Tool]
The objective of this protocol is to adapt and pilot test an existing lifestyle modification intervention for weight loss for women with overweight or obesity who have had a recent false positive mammography screen. The purpose of this pilot trial is to establish feasibility of Connect Online to Engage Change Tool (CONECT) to promote weight loss through increased physical activity and diet change.
- Conditions
- Weight Loss, Breast Cancer Risk Factors
- Being tested
- CONECT
- Keywords
- Physical activity, Diet, Nutrition, Breast cancer prevention, Mammography screening
- Medical subject headings
- Weight Loss, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CONECTBehavioural
1 monthly in person + 1 monthly telephone + 4 monthly email contact for behavior modification. Focus on motivation, self efficacy and information provision.
| Study group | Role | What they receive |
|---|---|---|
| CONECT | Experimental | 12 week program with additional follow up at 24 weeks. Receives: Behavioral: CONECT |
| Control | No intervention | Waitlist control. No intervention for first 12 weeks. Participants given the option to participate in the program after 24 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
feasibility-participant engagement and retention
recruitment of 30 participants with 70% retention at 12 weeks
Measured: 12 weeks
feasibility-intervention adherence
Completion of 80% of intention components including wearing Fitbit tracker, completed of the weekly weightings, answering emails, attending intervention sessions
Measured: 12 weeks
Secondary outcomes (4)
Change in autonomous motivation
Motivation assessment and feedback.
Measured: 12 weeks and 24 weeks
Steps per day
participants will be asked to use the Fitbit Heart Rate (HR) Physical Activity Monitor to track daily steps and minutes of physical activity.
Measured: 12 and 24 weeks
Total minutes of weekly physical activity
assessed by 7 day Physical Activity Recall Scale (PAR)
Measured: 12 and 24 weeks
Daily caloric goals
assessed by Automated Self-Administered (ASA) 24
Measured: 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2016 (estimated)
- Study start30 May 2017
- Primary completion28 Feb 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria D Thomson, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02871388
- Sponsor's protocol ID
- MCC-16-12892
- Other IDs
- HM20008111
- Status last verified
- Jul 2019
- First submitted
- 15 Aug 2016
- Last updated
- 9 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Modifiable Breast Cancer Risk Factors With Project CONECT [Connect Online to Engage Change Tool]
- ClinicalTrials.gov ID
- NCT02871388
- Acronym / sponsor ID
- MCC-16-12892
- Conditions
- Weight Loss, Breast Cancer Risk Factors
- Keywords
- Physical activity, Diet, Nutrition, Breast cancer prevention, Mammography screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 30 May 2017 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 18 Aug 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.
The objective of this protocol is to adapt and pilot test an existing lifestyle modification intervention for weight loss for women with overweight or obesity who have had a recent false positive mammography screen. The purpose of this pilot trial is to establish feasibility of Connect Online to Engage Change Tool (CONECT) to promote weight loss through increased physical activity and diet change.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CONECT | Experimental | Behavioral: CONECT12 week program with additional follow up at 24 weeks. |
| Control | No intervention | –Waitlist control. No intervention for first 12 weeks. Participants given the option to participate in the program after 24 weeks. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female
- 40-65 years of age,
- Received a negative mammography screening result in the previous four weeks
- Moderately sedentary lifestyle (less than 120 minutes/week moderate intensity activity),
- Answer "no" to all questions on the Physical Activity Readiness Questionnaire (PAR-Q).
Key exclusion criteria (6 listed)
- Previous history or current diagnosis of breast cancer
- Pregnancy or lactation
- Involvement in a weight loss program
- Major co-morbidities (e.g.,diabetes, hypertension, etc.)
- History of disordered eating
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 |
|---|---|---|
| CONECT1 monthly in person + 1 monthly telephone + 4 monthly email contact for behavior modification. Focus on motivation, self efficacy and information provision. | Behavioural | CONECT |
Primary outcome
feasibility-participant engagement and retention
Time frame: 12 weeks
recruitment of 30 participants with 70% retention at 12 weeks
feasibility-intervention adherence
Time frame: 12 weeks
Completion of 80% of intention components including wearing Fitbit tracker, completed of the weekly weightings, answering emails, attending intervention sessions
4 secondary outcomes
Change in autonomous motivation
Time frame: 12 weeks and 24 weeks
Steps per day
Time frame: 12 and 24 weeks
Total minutes of weekly physical activity
Time frame: 12 and 24 weeks
Daily caloric goals
Time frame: 12 and 24 weeks
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 9 Jul 2019.
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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.
Maria D Thomson, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CONECT in people with Weight Loss and Breast Cancer Risk Factors, run by Virginia Commonwealth University at 1 site in United States.
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 8 inclusion and 6 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 9 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
feasibility-participant engagement and retention (time frame: 12 weeks). 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?
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 9 Jul 2019; AzTrials last refreshed its copy on 6 Nov 2026.