NCT03006328

Brief Summary

The GEM intervention leverages the patient-centered medical home model by using the GEM tool to provide individually tailored, patient-centered care, promote standardized weight management counseling by health coaches and primary team members, coordinate care between teams and other weight management service providers/programs (e.g., dietitians, health educators, DPP), and provide feedback to the provider and primary care team about patients' weight management-related goals, progress, and care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
489

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 30, 2016

Completed
11 months until next milestone

Study Start

First participant enrolled

November 20, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2020

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2022

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

April 27, 2023

Completed
Last Updated

April 27, 2023

Status Verified

April 1, 2023

Enrollment Period

2.5 years

First QC Date

December 20, 2016

Results QC Date

February 24, 2023

Last Update Submit

April 6, 2023

Conditions

Weight GainObesity

Keywords

weight gainweight loss

Outcome Measures

Primary Outcomes (4)

  • Change in Weight From Baseline

    Baseline, Month 12

  • Change in Waist Circumference From Baseline

    Baseline, Month 12

  • Change in Systolic Blood Pressure (SBP) From Baseline

    Baseline, Month 12

  • Change in Diastolic Blood Pressure (DBP) From Baseline

    Baseline, Month 12

Study Arms (2)

Participants with Obesity + GEM

EXPERIMENTAL

Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity. Will be assigned to GEM Tool and a health coach.

Behavioral: GEM

Participants with Obesity + Enhanced Usual Care

ACTIVE COMPARATOR

Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity. Will receive receive non-tailored weight management handouts by health coaches.

Behavioral: Enhanced Usual Care

Interventions

GEMBEHAVIORAL

Online program designed to support health coach and primary care team counseling. It assesses current behaviors, barriers, and facilitators to weight loss via a 16-item questionnaire, provides tailored advice, and guides patients to set weight loss (5-10%), diet, and physical activity (PA) goals. After completing the tool, participants will meet with a Health Coach. Participants will receive 12 telephone coaching calls by a health coach over 12 months.

Participants with Obesity + GEM
Enhanced Usual CareBEHAVIORAL

Patients in the EUC arm will receive non-tailored weight management handouts. Patients will follow-up with their primary care teams as needed.

Participants with Obesity + Enhanced Usual Care

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Between the ages of 18-69 years of age,
  • Body mass index of ≥30kg/m2 OR
  • Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity
  • Hypertension
  • High Cholesterol
  • Sleep Apnea
  • Osteoarthritis
  • Metabolic Syndrome
  • Prediabetes
  • Under primary care team care with at least one prior visit with their provider in the past 24 months
  • Access to a telephone, and ability to travel for in-person evaluations at baseline, 6, 12, and 24 months

You may not qualify if:

  • Patients who do not speak English or Spanish,
  • Have active psychosis or other cognitive issues,
  • Psychoactive substance use
  • Diabetes
  • Taking prescription weight-loss medication
  • Health condition that may prohibit the patient from walking or physical activity such as chest tightness, a heart condition, or severe arthritis
  • Participated in MOVE!, DPP, or another intensive weight management program (\>3 sessions) in the past year,
  • Have a history of bariatric surgery,
  • Are pregnant, or become pregnant during the intervention period,
  • Metastatic cancer in the last 6 months, current chemotherapy or cancer treatment,
  • Have a provider who states they should not participate,
  • Patients who do not want to lose weight
  • Have self-reported inability to read at 5th grade level.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University Medical Center Institutional Review Boards

New York, New York, 10016, United States

Location

Related Publications (3)

  • Merriwether EN, Wittleder S, Cho G, Bogan E, Thomas R, Bostwick N, Wang B, Ravenell J, Jay M. Racial and weight discrimination associations with pain intensity and pain interference in an ethnically diverse sample of adults with obesity: a baseline analysis of the clustered randomized-controlled clinical trial the goals for eating and moving (GEM) study. BMC Public Health. 2021 Dec 2;21(1):2201. doi: 10.1186/s12889-021-12199-1.

    PMID: 34856961DERIVED

  • Wittleder S, Ajenikoko A, Bouwman D, Fang Y, McKee MD, Meissner P, Orstad SL, Rehm CD, Sherman SE, Smith S, Sweat V, Velastegui L, Wylie-Rosett J, Jay M. Protocol for a cluster-randomized controlled trial of a technology-assisted health coaching intervention for weight management in primary care: The GEM (goals for eating and moving) study. Contemp Clin Trials. 2019 Aug;83:37-45. doi: 10.1016/j.cct.2019.06.005. Epub 2019 Jun 20.

    PMID: 31229622DERIVED

  • Viglione C, Bouwman D, Rahman N, Fang Y, Beasley JM, Sherman S, Pi-Sunyer X, Wylie-Rosett J, Tenner C, Jay M. A technology-assisted health coaching intervention vs. enhanced usual care for Primary Care-Based Obesity Treatment: a randomized controlled trial. BMC Obes. 2019 Feb 4;6:4. doi: 10.1186/s40608-018-0226-0. eCollection 2019.

    PMID: 30766686DERIVED

MeSH Terms

Conditions

Weight GainObesityWeight Loss

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic Diseases

Results Point of Contact

Title
Sandra Wittleder, PhD
Organization
NYU Langone Health
sandra.wittleder@nyulangone.org
212-263-4149

Study Officials

  • Melanie Jay, MD

    NYU School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2016

First Posted

December 30, 2016

Study Start

November 20, 2017

Primary Completion

May 20, 2020

Study Completion

February 22, 2022

Last Updated

April 27, 2023

Results First Posted

April 27, 2023

Record last verified: 2023-04

Locations

US(1)