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Effects of Behavioral Interventions on Weight Loss and Weight Maintenance

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ClinicalTrials.gov Identifier: NCT04190069
Recruitment Status : Withdrawn (IRB recommended change to registry study or quality improvement project status)
First Posted : December 9, 2019
Last Update Posted : June 25, 2020
Sponsor:
Information provided by (Responsible Party):
David Rometo, University of Pittsburgh

Brief 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 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.

Condition or disease Intervention/treatment Phase
Behavior Behavioral: Behavioral interventions/modifications Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effects of Behavioral Interventions on Weight Loss and Weight Maintenance
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: OPTIFAST only
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.
Experimental: UPMC PFW followed by OPTIFAST
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.
Behavioral: Behavioral interventions/modifications
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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Change from baseline in blood pressure at 18 months [ Time Frame: 18 months ]
    change in blood pressure over time in participants who undergo behavioral interventions compared to those who do not.

  2. Change from baseline in A1c at 18 months [ Time Frame: 18 months ]
    change in A1c over time in participants who undergo behavioral interventions compared to those who do not.

  3. Change from baseline in lipid profile at 18 months [ Time Frame: 18 months ]
    change in lipid profile overtime in participants who undergo behavioral interventions compared to those who do not.

  4. Change from baseline in medication burden (number of medications) at 18 months [ Time Frame: 18 months ]
    Change in medication burden (number of medications) pertaining to type 2 DM and hypertension over time

  5. Change from baseline in medication burden (dose of medications) at 18 months [ Time Frame: 18 months ]
    Change in medication burden (dose of medications) pertaining to type 2 DM and hypertension over time



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or female aged 18 yrs or older
  2. BMI >40 kg/m2
  3. 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.

Exclusion Criteria:

  1. Binge eating disorder (Bulemia, Anorexia nervosa)
  2. Congestive heart failure NYHA Class >3
  3. >Stage 3 chronic kidney disease
  4. Cardiovascular disease (non-fatal MI, non-fatal stroke, peripheral vascular disease) within the past 6 months of screening
  5. Planned coronary artery, carotid artery or peripheral artery revascularization
  6. Weight loss surgery (gastric bypass, sleeve gastrectomy, total/subtotal gastrectomy) within the past 2 yrs.
  7. Pregnant and lactating females
  8. Active malignancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04190069


Sponsors and Collaborators
University of Pittsburgh
Investigators
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Principal Investigator: David Rometo, M.D University of Pittsburgh
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Responsible Party: David Rometo, Clinical Director for UPMC Center for Obesity Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT04190069    
Other Study ID Numbers: STUDY19100189
First Posted: December 9, 2019    Key Record Dates
Last Update Posted: June 25, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by David Rometo, University of Pittsburgh:
weight loss, weight maintenance
Additional relevant MeSH terms:
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Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms