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Metformin for Overweight & OBese ChILdren and Adolescents With BDS Treated With SGAs

NCT02515773 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1565

Last updated 2025-01-14

Study results available
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Summary

A prospective, large, pragmatic, randomized trial to study the impact of METFORMIN and healthy lifestyle intervention (LIFE) vs. LIFE alone on patient-centered outcomes of body weight, SGA-adherence and satisfaction, psychiatric symptom burden (e.g. mood/anxiety), and Quality of Life.

Conditions

Interventions

DRUG

Metformin

Metformin - to achieves maximum insulin-sensitizing effects

BEHAVIORAL

healthy lifestyle intervention (LIFE)

Healthy Life style intervention

Sponsors & Collaborators

  • Patient-Centered Outcomes Research Institute

    collaborator OTHER

  • Melissa Delbello

    lead OTHER

Principal Investigators

  • Melissa P DelBello, MD, MS · University of Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2022-12-31
Completion
2023-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02515773 on ClinicalTrials.gov