Effects of Behavioral Interventions on Weight Loss and Weight Maintenance

NCT04190069 | Withdrawn

• 1 other identifier: STUDY19100189
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Behavior

Keywords

weight loss, weight maintenance

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Change from baseline in blood pressure at 18 months

  18 months

• Change from baseline in A1c at 18 months

  18 months

• Change from baseline in lipid profile at 18 months

  18 months

• Change from baseline in medication burden (number of medications) at 18 months

  18 months

• Change from baseline in medication burden (dose of medications) at 18 months

  18 months

Study Arms (2)

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.

Behavioral: Behavioral interventions/modifications

Interventions

Behavioral interventions/modifications BEHAVIORAL

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.

UPMC PFW followed by OPTIFAST

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead

MeSH Terms

Conditions

Behavior; Weight Loss

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• David Rometo, M.D

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Director for UPMC Center for Obesity Medicine

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 9, 2019
• Study Start: January 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: June 25, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share