BehaviorNCT04190069
Effects of Behavioral Interventions on Weight Loss and Weight Maintenance
A study testing Behavioral interventions/modifications in people with Behavior, run by University of Pittsburgh.
Trial summary
The objective of the study is to examine the extent to which diet/lifestyle change programs with a multidisciplinary team (consisting of a dietician, physician and behaviorist/health coach) that develop healthy behaviors before creating a calorie deficit for weight loss will result in greater weight loss and a longer… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Behavior
- What is being tested?
- Behavioral interventions/modifications
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2020to Dec 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female aged 18 yrs or older
- BMI >40 kg/m2
- BMI between 35-40 kg/m2 with obesity-related co-morbidities including type 2 diabetes mellitus, hypertension, dyslipidemia. Type 2 Diabetes Mellitus defined by A1c >6.4% with or without oral hypoglycemic agents and with or without insulin therapy. Hypertension defined by blood pressure >140/80 mm of hg with or without antihypertensive therapy. Dyslipidemia defined as fasting lipid profile with one or more of the following abnormalities: serum cholesterol levels >200 mg/dl, serum triglyceride levels >150 mg/dl, HDL levels <50 mg/dl, LDL levels >100 mg/dl with or without therapy.
Who cannot join
- Binge eating disorder (Bulemia, Anorexia nervosa)
- Congestive heart failure NYHA Class >3
- >Stage 3 chronic kidney disease
- Cardiovascular disease (non-fatal MI, non-fatal stroke, peripheral vascular disease) within the past 6 months of screening
- Planned coronary artery, carotid artery or peripheral artery revascularization
- Weight loss surgery (gastric bypass, sleeve gastrectomy, total/subtotal gastrectomy) within the past 2 yrs.
- Pregnant and lactating females
- Active malignancy
About this study
The objective of the study is to examine the extent to which diet/lifestyle change programs with a multidisciplinary team (consisting of a dietician, physician and behaviorist/health coach) that develop healthy behaviors before creating a calorie deficit for weight loss will result in greater weight loss and a longer duration of weight maintenance. It intends to compare the extent of weight loss and weight maintenance in participants who will undergo calorie restriction without prior behavioral interventions to participants that will undergo behavioral interventions prior to starting calorie restriction.
Read the detailed description
OPTIFAST is a medically supervised weight loss and weight management program that involves a complete meal replacement followed by a gradual introduction of foods after dietary education. The resources offered through this program are through a physician, registered dietitian and behaviorist, including a psychologist.
UPMC Prescription for Wellness is an innovative physician/provider prescribed coaching and feedback program that improves patient engagement and outcomes in healthy behaviors; self-care of chronic disease and condition management; and shared decision-making. The resources available through this program are offered via a telephonic health coach, online or through a digital intervention based on the participant's convenience.
The objective of the study is to examine the extent to which diet/lifestyle change programs with a multidisciplinary team (consisting of a dietician, physician and behaviorist/health coach) that develop healthy behaviors before creating a calorie deficit for weight loss will result in greater weight loss and a longer duration of weight maintenance. It intends to compare the extent of weight loss and weight maintenance in participants who will undergo calorie restriction without prior behavioral interventions to participants that will undergo behavioral interventions prior to starting calorie restriction.
Behavioral interventions will first be provided by UPMC Prescription for Wellness prior to starting OPTIFAST. Calorie restriction will be during the OPTIFAST Program. The participants will be actively recruited by the study team at the Center for Diabetes and Metabolism (CDE) at the Falk Clinic in Oakland, Pittsburgh.
- Conditions
- Behavior
- Being tested
- Behavioral interventions/modifications
- Keywords
- weight loss, weight maintenance
- Medical subject headings
- Behavior, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral interventions/modificationsBehavioural
UPMC Prescription for Wellness is an innovative physician/provider prescribed coaching and feedback program that improves patient engagement and outcomes in healthy behaviors; self-care of chronic disease and condition management; and shared decision-making. The resources available through this program are offered via a telephonic health coach, online or through a digital intervention based on the participant's convenience.
| Study group | Role | What they receive |
|---|---|---|
| OPTIFAST only | No intervention | Control group will consist of participants that have not undergone behavioral modifications with the Prescription for Wellness Program. These are participants that only go through the OPTIFAST Program. |
| UPMC PFW followed by OPTIFAST | Experimental | The intervention group will consist of participants that have undergone behavioral modifications with the Prescription for Wellness Program. These are participants who undergo the Prescription for Wellness Program prior to the OPTIFAST Program. Receives: Behavioral: Behavioral interventions/modifications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in body weight at 6 months
The degree of weight loss in those who undergo behavioral modifications prior to starting calorie restriction compared to those who do not undergo behavioral modifications prior to starting calorie restriction.
Measured: 6 months
Change from 6 months in body weight at 18 months
The duration of weight maintenance in those who undergo behavioral modifications prior to starting calorie restriction compared to those who do not undergo behavioral modifications prior to starting calorie restriction.
Measured: 6 months vs 18 months
Secondary outcomes (5)
Change from baseline in blood pressure at 18 months
change in blood pressure over time in participants who undergo behavioral interventions compared to those who do not.
Measured: 18 months
Change from baseline in A1c at 18 months
change in A1c over time in participants who undergo behavioral interventions compared to those who do not.
Measured: 18 months
Change from baseline in lipid profile at 18 months
change in lipid profile overtime in participants who undergo behavioral interventions compared to those who do not.
Measured: 18 months
Change from baseline in medication burden (number of medications) at 18 months
Change in medication burden (number of medications) pertaining to type 2 DM and hypertension over time
Measured: 18 months
Change from baseline in medication burden (dose of medications) at 18 months
Change in medication burden (dose of medications) pertaining to type 2 DM and hypertension over time
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study startJan 2020 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: IRB recommended change to registry study or quality improvement project status
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BehaviorStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Rometo, University of Pittsburgh
- Investigators
- David Rometo, M.D, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04190069
- Sponsor's protocol ID
- STUDY19100189
- Status last verified
- Jun 2020
- First submitted
- 4 Dec 2019
- Last updated
- 25 Jun 2020
- 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 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Behavioral Interventions on Weight Loss and Weight Maintenance
- ClinicalTrials.gov ID
- NCT04190069
- Acronym / sponsor ID
- STUDY19100189
- Conditions
- Behavior
- Keywords
- weight loss, weight maintenance
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: IRB recommended change to registry study or quality improvement project status
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Jan 2020 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 9 Dec 2019 (actual)
- 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 the study is to examine the extent to which diet/lifestyle change programs with a multidisciplinary team (consisting of a dietician, physician and behaviorist/health coach) that develop healthy behaviors before creating a calorie deficit for weight loss will result in greater weight loss and a longer duration of weight maintenance. It intends to compare the extent of weight loss and weight maintenance in participants who will undergo calorie restriction without prior behavioral interventions to participants that will undergo behavioral interventions prior to starting calorie restriction.
Detailed description
OPTIFAST is a medically supervised weight loss and weight management program that involves a complete meal replacement followed by a gradual introduction of foods after dietary education. The resources offered through this program are through a physician, registered dietitian and behaviorist, including a psychologist.
UPMC Prescription for Wellness is an innovative physician/provider prescribed coaching and feedback program that improves patient engagement and outcomes in healthy behaviors; self-care of chronic disease and condition management; and shared decision-making. The resources available through this program are offered via a telephonic health coach, online or through a digital intervention based on the participant's convenience.
The objective of the study is to examine the extent to which diet/lifestyle change programs with a multidisciplinary team (consisting of a dietician, physician and behaviorist/health coach) that develop healthy behaviors before creating a calorie deficit for weight loss will result in greater weight loss and a longer duration of weight maintenance. It intends to compare the extent of weight loss and weight maintenance in participants who will undergo calorie restriction without prior behavioral interventions to participants that will undergo behavioral interventions prior to starting calorie restriction.
Behavioral interventions will first be provided by UPMC Prescription for Wellness prior to starting OPTIFAST. Calorie restriction will be during the OPTIFAST Program. The participants will be actively recruited by the study team at the Center for Diabetes and Metabolism (CDE) at the Falk Clinic in Oakland, Pittsburgh.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OPTIFAST only | No intervention | –Control group will consist of participants that have not undergone behavioral modifications with the Prescription for Wellness Program. These are participants that only go through the OPTIFAST Program. |
| UPMC PFW followed by OPTIFAST | Experimental | Behavioral: Behavioral interventions/modificationsThe intervention group will consist of participants that have undergone behavioral modifications with the Prescription for Wellness Program. These are participants who undergo the Prescription for Wellness Program prior to the OPTIFAST Program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female aged 18 yrs or older
- BMI >40 kg/m2
- BMI between 35-40 kg/m2 with obesity-related co-morbidities including type 2 diabetes mellitus, hypertension, dyslipidemia. Type 2 Diabetes Mellitus defined by A1c >6.4% with or without oral hypoglycemic agents and with or without insulin therapy. Hypertension defined by blood pressure >140/80 mm of hg with or without antihypertensive therapy. Dyslipidemia defined as fasting lipid profile with one or more of the following abnormalities: serum cholesterol levels >200 mg/dl, serum triglyceride levels >150 mg/dl, HDL levels <50 mg/dl, LDL levels >100 mg/dl with or without therapy.
Key exclusion criteria (8 listed)
- Binge eating disorder (Bulemia, Anorexia nervosa)
- Congestive heart failure NYHA Class >3
- >Stage 3 chronic kidney disease
- Cardiovascular disease (non-fatal MI, non-fatal stroke, peripheral vascular disease) within the past 6 months of screening
- Planned coronary artery, carotid artery or peripheral artery revascularization
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 |
|---|---|---|
| Behavioral interventions/modificationsUPMC Prescription for Wellness is an innovative physician/provider prescribed coaching and feedback program that improves patient engagement and outcomes in healthy behaviors; self-care of chronic disease and condition management; and shared decision-making. The resources available through this program are offered via a telephonic health coach, online or through a digital intervention based on the participant's convenience. | Behavioural | UPMC PFW followed by OPTIFAST |
Primary outcome
Change from baseline in body weight at 6 months
Time frame: 6 months
The degree of weight loss in those who undergo behavioral modifications prior to starting calorie restriction compared to those who do not undergo behavioral modifications prior to starting calorie restriction.
Change from 6 months in body weight at 18 months
Time frame: 6 months vs 18 months
The duration of weight maintenance in those who undergo behavioral modifications prior to starting calorie restriction compared to those who do not undergo behavioral modifications prior to starting calorie restriction.
5 secondary outcomes
Change from baseline in blood pressure at 18 months
Time frame: 18 months
Change from baseline in A1c at 18 months
Time frame: 18 months
Change from baseline in lipid profile at 18 months
Time frame: 18 months
Change from baseline in medication burden (number of medications) at 18 months
Time frame: 18 months
Change from baseline in medication burden (dose of medications) at 18 months
Time frame: 18 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2020.
- 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.
David Rometo, M.D principal investigator
University of Pittsburgh
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral interventions/modifications in people with Behavior, run by University of Pittsburgh.
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 3 inclusion and 8 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: withdrawn, as of the sponsor's last update on 25 Jun 2020. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change from baseline in body weight at 6 months (time frame: 6 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?
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 25 Jun 2020.