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Weight GainGEMNCT03006328

The GEM (Goals for Eating and Moving) Study

A study testing GEM in people with Weight Gain and Obesity, run by NYU Langone Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 69 years
Conditions the study is for
Weight Gain, Obesity
What is being tested?
GEM
Could I receive a placebo?
No, everyone receives an active treatment
How many people
489 participants
Where
1 siteUnited States
Study dates
20 Nov 2017to 22 Feb 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 69 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • New York University Medical Center Institutional Review Boards

    New York, New York, 10016

Other trials in United States

About this study

Official title: Technology-Assisted Weight Management Intervention Within Patient-Centered Medical Homes: The GEM (Goals for Eating and Moving) Study

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.

Read the detailed description

To establish the efficacy of the GEM intervention, investigators will conduct a cluster randomized controlled 12-month intervention of 19 primary care teams at two urban healthcare systems with Medical Home models of care to compare the GEM intervention (intervention arm) with Enhanced Usual Care (educational materials; control arm).

The specific aims of this study are:

  • Test the impact of the GEM intervention on weight change, and clinical and behavioral outcomes.
  • Identify predictors of weight loss in the GEM intervention arm related to: a) goal-setting processes and b) intervention components
  • Determine the impact of the GEM intervention on obesity-related counseling practices and attitudes in primary care providers.
Conditions
Weight Gain, Obesity
Being tested
GEM, Enhanced Usual Care
Keywords
weight gain, weight loss
Medical subject headings
Weight Gain, Obesity, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GEMBehavioural

    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.

  • Enhanced Usual CareBehavioural

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

Study groups in NCT03006328
Study groupRoleWhat they receive
Participants with Obesity + GEMExperimentalBody 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.
Receives: Behavioral: GEM
Participants with Obesity + Enhanced Usual CareActive comparatorBody 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.
Receives: Behavioral: Enhanced Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Weight From Baseline

    Measured: Baseline, Month 12

  2. Change in Waist Circumference From Baseline

    Measured: Baseline, Month 12

  3. Change in Systolic Blood Pressure (SBP) From Baseline

    Measured: Baseline, Month 12

  4. Change in Diastolic Blood Pressure (DBP) From Baseline

    Measured: Baseline, Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2016 (estimated)
  2. Study start20 Nov 2017
  3. Primary completion20 May 2020
  4. Study completion22 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
489 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03006328
Sponsor's protocol ID
16-01445
Acronym
GEM
Status last verified
Apr 2023
First submitted
20 Dec 2016
Last updated
27 Apr 2023
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Jay MR, Wittleder S, Vandyousefi S, Illenberger N, Nicholson A, Sweat V, Meissner P, Angelotti G, Ruan A, Wong L, Aguilar AD, Orstad SL, Sherman S, Armijos E, Belli H, Wylie-Rosett J. A Cluster-Randomized Study of Technology-Assisted Health Coaching for Weight Management in Primary Care. Ann Fam Med. 2024 Sep-Oct;22(5):392-399. doi: 10.1370/afm.3150.

    PubMed 39313341

  • 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.

    PubMed 34856961

  • 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.

    PubMed 31229622

  • 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.

    PubMed 30766686

Questions about this trial

What is this clinical trial studying?

A study testing GEM in people with Weight Gain and Obesity, run by NYU Langone Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Weight From Baseline (time frame: Baseline, Month 12). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03006328, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2023.

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