Effects of Behavioral Interventions on Weight Loss and Weight Maintenance

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.

Study Overview

• Status: Withdrawn
• Conditions: Behavior
• Intervention / Treatment: Behavioral: Behavioral interventions/modifications

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 Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	6 months vs 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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	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	18 months

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Investigators: Principal Investigator: David Rometo, M.D, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2020
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: December 4, 2019
• First Submitted That Met QC Criteria: December 4, 2019
• First Posted (Actual): December 9, 2019

Study Record Updates

• Last Update Posted (Actual): June 25, 2020
• Last Update Submitted That Met QC Criteria: June 22, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: weight loss, weight maintenance
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: STUDY19100189

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No