Lifestyle Modification and Liraglutide

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT02911818
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • CMS-recommended lifestyle counseling — BEHAVIORAL
    21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
  • Liraglutide 3.0mg — DRUG
    Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
  • Portion-Controlled Diet — OTHER
    A 1000-1200 kcal/day portion-controlled diet prescribed for 12 weeks.
  • Placebo Oral Tablet — DRUG
  • Phentermine 15 MG — DRUG
  • Extension Study CMS-recommended lifestyle counseling — BEHAVIORAL
    4 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.

Study Details

This is a 52 week, single center, open-labeled, randomized controlled trial. A total of 150 subjects with obesity, who are free of types 1 and 2 diabetes, as well as contraindications to weight loss, will be randomly assigned to one of three treatment groups: 1) lifestyle counseling, as currently recommended by the Centers for Medicare and Medicaid Services (CMS) (i.e., CMS-Alone); 2) CMS lifestyle counseling plus liraglutide (i.e., CMS-Liraglutide); or 3) CMS-Liraglutide plus a portion-controlled diet (i.e., Multi-Component Intervention). Subjects in all three groups will have 14 brief (15 minute) lifestyle counseling visits the first 24 weeks, followed by monthly visits in weeks 25-52. This is the schedule and duration of counseling visits recommended by CMS. Counseling sessions will be delivered by a physician, nurse practitioner or registered dietitian (RD) working in consultation with the former providers. Subjects in all three groups also will have brief physician visits at weeks 1, 4, 8, 16, 24, 36, and 52 (total of 7 visits). These visits are needed for subjects in both liraglutide groups to monitor their response to the medication. These visits are included for subjects in CMS-Alone to match the intensity of medical care provided the two other groups. The primary outcome is % reduction in initial body weight, as measured from randomization to week 52. Secondary outcomes include the proportion of participants who at week 52 lose \>5%, \>10%, and \>15% of initial weight, as well as % reduction in weight at week 24 and the proportion of participants who meet the three categorical weight losses at this time. The secondary efficacy measures include changes (from randomization to week 52) in cardiovascular disease (CVD) risk factors, glycemic control, mood, quality of life, eating behavior, appetite, sleep, and satisfaction with weight loss. Safety endpoints will include physical examination, adverse events (AEs), standard laboratory tests, and mental health assessed by the Columbia Suicidality Severity Rating Scale (C-SSRS) and Patient Health Questionnaire (PHQ-9). Statistical Analysis. Using a sample size equation for longitudinal clustered samples, a randomization sample of 50 subjects in CMS-Alone, 50 in CMS-Liraglutide, and 50 in the Multi-Component Intervention provides \>80% power to detect the two primary contrasts to be statistically significant. This estimate allows for 20% attrition during the 52-week trial, resulting in approximately 40 treatment completers per group. The ITT longitudinal statistical design will further improve power by allowing the inclusion of available data for non-completers and the adjustment of possible variance reducing baseline covariates.

Key Dates

Start date
Sep 30, 2016
Status verified
Apr 2019
Primary completion
Nov 30, 2018
Completion
Dec 31, 2018

Study Design

Enrollment
150 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: CMS-Alone
    Lifestyle counseling, as currently recommended by the CMS.
  • Active Comparator: CMS-Liraglutide
    CMS lifestyle counselling plus liraglutide.
  • Active Comparator: Multi-Component Intervention
    CMS-Liraglutide plus a 1000-1200 kcal/day portion-controlled diet prescribed for 12 weeks.
  • Active Comparator: 12-Week Extension Study: Phentermine Group
    After the 1-year trial, half the participants who join the extension study will be randomized to phentermine 15.0 mg/d in a double-blind fashion, while continuing to take liraglutide. They will also continue to receive monthly lifestyle counseling. To be eligible for the extension study, participants must have been assigned to one of two medication groups in the original study.
  • Active Comparator: 12-Week Extension Study: Placebo Group
    After the 1-year trial, half the participants who join the extension study will be randomized to placebo in a double-blind fashion, while continuing to take liraglutide. They will also continue to receive monthly lifestyle counseling. To be eligible for the extension study, participants must have been assigned to one of two medication groups in the original study.

Primary Outcome Measure

Percent Change in Baseline Weight [ Time Frame: Randomization and 52 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Pennsylvania Center for Weight and Eating DisordersPhiladelphiaPennsylvania19104-

Find similar trials in Philadelphia, PA

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
University of Pennsylvania Center for Weight and Eating Disorders· Philadelphia, PA

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