Health BehaviorNCT02752464
Behavioral CVD Prevention Using Informatics
A study testing Counseling and feedback report in people with Health Behavior, run by Boston Medical Center at 1 site in United States.
Trial summary
Overweight/obesity is strongly linked to mortality from multiple chronic diseases, including cardiovascular disease, diabetes, and obesity-related cancers.The successful management of overweight/obesity requires management of nutrition and physical activity over time. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Health Behavior
- What is being tested?
- Counseling and feedback report
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2016to 1 Jun 2018
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing to wear an accelerometer
- 18-65 years old
- Public housing resident with no plans to move in next 6 months
- Body mass index ≥25
- Open to making changes to diet \& physical activity habits
Who cannot join
- Currently enrolled in a comprehensive weight loss program or a research study whose primary outcome is weight loss
- Primary language spoken is a language other than Spanish or English
- Not willing to participate in study protocols, including wearing the accelerometer, not willing to have study staff send text messages
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Behavioral Cardiovascular Disease Prevention Using Informatics
Overweight/obesity is strongly linked to mortality from multiple chronic diseases, including cardiovascular disease, diabetes, and obesity-related cancers.The successful management of overweight/obesity requires management of nutrition and physical activity over time. For racial/ethnic minority and low-income populations, who face both higher prevalence of obesity and chronic diseases compared to others, interventions promoting behavioral change are a national health priority. From the available range of behavioral change intervention strategies, there is a growing knowledge base that documents the efficacy of peer support interventions for improving self-care, quality of life, and behavioral change. In this study, the investigators will examine the following research question: What is the preliminary efficacy and degree of implementation and acceptability of an intervention approach in which peer counselors provide evidenced-based counseling about nutrition and physical activity behaviors for weight management to public housing residents using a computer-assisted program called CuesWeight?
- Conditions
- Health Behavior
- Being tested
- Counseling, feedback report
- Keywords
- Weight Loss, Health Status Disparities
- Medical subject headings
- Health Behavior, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CounselingBehavioural
Up to 12 sessions of behavioral counseling using motivational interviewing techniques focused on diet and physical activity behaviors over a 12 week period. Counselors will be guided in their sessions by a computer program called CuesWeight. Participants also receive text messages to enable participants to track their behaviors; this information is relayed to the counselors to inform the counseling sessions.
feedback reportBehavioural
All participants receive a brief printed feedback report displaying their current levels of nutrition and physical activity behaviors and tips for meeting recommended guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Feedback report plus peer counseling | Experimental | Feedback report plus peer counseling Participants receive 12 sessions of behavioral counseling and a brief printed feedback report Receives: Behavioral: Counseling; Behavioral: feedback report |
| Feedback report | Active comparator | Feedback report Participants receive a brief printed feedback report Receives: Behavioral: feedback report |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight-objective measurement
Weight in pounds will be measured objectively with a digital scale
Measured: 12 weeks
Secondary outcomes (11)
Diet, fruits and vegetables, self-reported via questionnaire
Servings of fruits and vegetables will be measured via the Primescreen dietary screener instrument
Measured: 12 weeks
Diet, sugar sweetened beverages, self-reported via questionnaire
Fluid ounces of sugar sweetened beverages will be measured via the BEV-Q questionnaire
Measured: 12 weeks
Diet, fast food, self-reported via questionnaire
Number of visits to fast food restaurants will be measured via a 1-item question asking participants how often they go to fast food restaurants
Measured: 12 weeks
Physical activity, objectively measured
Minutes of light to moderate physical activity will be measured via accelerometers (Actigraphs)
Measured: 12 weeks
Physical activity, self-reported
Minutes of light to moderate physical activity will be measured via a questionnaire (IPAQ)
Measured: 12 weeks
Internal motivation, self-reported via questionnaire
Perceptions of internal motivation to change diet and physical activity will be measured by a brief questionnaire
Measured: 12 weeks
Self-efficacy for eating a healthful diet, self-reported via questionnaire
Perceptions of self-efficacy (or confidence) to change diet behaviors in a variety of situations will be measured by a brief questionnaire
Measured: 12 weeks
Self-efficacy for doing physical activity, self-reported via questionnaire
Perceptions of self-efficacy (or confidence) to change physical activity behaviors in a variety of situations will be measured by a brief questionnaire
Measured: 12 weeks
Social support, self-reported via questionnaire
Perceptions of social support from a variety of sources will be measured via a brief questionnaire
Measured: 12 weeks
Feasibility, number of counseling sessions completed
Number of counseling sessions completed in-person and over the phone will be tallied and reported
Measured: 12 weeks
Feasibility, acceptability of intervention
Perceptions of acceptability of both the brief feedback report and the counseling sessions will be asked in open- and closed-ended questions
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2016 (estimated)
- Study start14 Sep 2016
- Primary completion1 Jun 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe 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
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Lisa M. Quintiliani, Boston Medical Center
- Investigators
- Lisa M Quintiliani, PhD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02752464
- Sponsor's protocol ID
- H-34964
- Other IDs
- 14SDG20050015
- Status last verified
- Jun 2018
- First submitted
- 19 Apr 2016
- Last updated
- 2 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Cardiovascular Disease Prevention Using Informatics
- ClinicalTrials.gov ID
- NCT02752464
- Acronym / sponsor ID
- H-34964
- Conditions
- Health Behavior
- Keywords
- Weight Loss, Health Status Disparities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 14 Sep 2016 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 27 Apr 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.
Overweight/obesity is strongly linked to mortality from multiple chronic diseases, including cardiovascular disease, diabetes, and obesity-related cancers.The successful management of overweight/obesity requires management of nutrition and physical activity over time. For racial/ethnic minority and low-income populations, who face both higher prevalence of obesity and chronic diseases compared to others, interventions promoting behavioral change are a national health priority. From the available range of behavioral change intervention strategies, there is a growing knowledge base that documents the efficacy of peer support interventions for improving self-care, quality of life, and behavioral change. In this study, the investigators will examine the following research question: What is the preliminary efficacy and degree of implementation and acceptability of an intervention approach in which peer counselors provide evidenced-based counseling about nutrition and physical activity behaviors for weight management to public housing residents using a computer-assisted program called CuesWeight?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Feedback report plus peer counseling | Experimental | Behavioral: Counseling, Behavioral: feedback reportFeedback report plus peer counseling Participants receive 12 sessions of behavioral counseling and a brief printed feedback report |
| Feedback report | Active comparator | Behavioral: feedback reportFeedback report Participants receive a brief printed feedback report |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Willing to wear an accelerometer
- 18-65 years old
- Public housing resident with no plans to move in next 6 months
- Body mass index ≥25
- Open to making changes to diet \& physical activity habits
Key exclusion criteria (3 listed)
- Currently enrolled in a comprehensive weight loss program or a research study whose primary outcome is weight loss
- Primary language spoken is a language other than Spanish or English
- Not willing to participate in study protocols, including wearing the accelerometer, not willing to have study staff send text messages
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 |
|---|---|---|
| CounselingUp to 12 sessions of behavioral counseling using motivational interviewing techniques focused on diet and physical activity behaviors over a 12 week period. Counselors will be guided in their sessions by a computer program called CuesWeight. Participants also receive text messages to enable participants to track their behaviors; this information is relayed to the counselors to inform the counseling sessions. | Behavioural | Feedback report plus peer counseling |
| feedback reportAll participants receive a brief printed feedback report displaying their current levels of nutrition and physical activity behaviors and tips for meeting recommended guidelines. | Behavioural | Feedback report, Feedback report plus peer counseling |
Primary outcome
Weight-objective measurement
Time frame: 12 weeks
Weight in pounds will be measured objectively with a digital scale
11 secondary outcomes
Diet, fruits and vegetables, self-reported via questionnaire
Time frame: 12 weeks
Diet, sugar sweetened beverages, self-reported via questionnaire
Time frame: 12 weeks
Diet, fast food, self-reported via questionnaire
Time frame: 12 weeks
Physical activity, objectively measured
Time frame: 12 weeks
Physical activity, self-reported
Time frame: 12 weeks
Internal motivation, self-reported via questionnaire
Time frame: 12 weeks
Self-efficacy for eating a healthful diet, self-reported via questionnaire
Time frame: 12 weeks
Self-efficacy for doing physical activity, self-reported via questionnaire
Time frame: 12 weeks
Social support, self-reported via questionnaire
Time frame: 12 weeks
Feasibility, number of counseling sessions completed
Time frame: 12 weeks
Feasibility, acceptability of intervention
Time frame: 12 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 2 Jul 2018.
- Individual participant dataSharing planned: No
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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.
Lisa M Quintiliani, PhD principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counseling and feedback report in people with Health Behavior, run by Boston Medical Center 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 5 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 2 Jul 2018. 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?
Weight-objective measurement (time frame: 12 weeks). 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 2 Jul 2018.