Clinical trial NCT04190069: Effects of Behavioral Interventions on Weight Loss and Weight Maintenance
Official title: Effects of Behavioral Interventions on Weight Loss and Weight Maintenance
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Behavior
Keywords: weight loss, weight maintenance
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2019-12-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Eligibility 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

Primary outcomes:
measure: Change from baseline in body weight at 6 months
timeFrame: 6 months
measure: Change from 6 months in body weight at 18 months
timeFrame: 6 months vs 18 months
Secondary outcomes:
measure: Change from baseline in blood pressure at 18 months
timeFrame: 18 months
measure: Change from baseline in A1c at 18 months
timeFrame: 18 months
measure: Change from baseline in lipid profile at 18 months
timeFrame: 18 months
measure: Change from baseline in medication burden (number of medications) at 18 months
timeFrame: 18 months
measure: Change from baseline in medication burden (dose of medications) at 18 months
timeFrame: 18 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Pittsburgh
name: David Rometo, M.D
role: PRINCIPAL_INVESTIGATOR
References: