Effects of Behavioral Interventions on Weight Loss and Weight Maintenance

Behavior Clinical Trial

Official title:

Effects of Behavioral Interventions on Weight Loss and Weight Maintenance

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04190069
• Other study ID #: STUDY19100189
• Status: Withdrawn
• Phase: N/A
• Start date: January 2020
• Est. completion date: December 2022

Study information

• Verified date: June 2020
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Behavior
• Weight Loss

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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