NCT05938933

Brief Summary

Obesity affects a large portion of our population and accounts for a significant individual health burden for both individual patients and society. Though as little as 3 to 5% weight loss is associated with significant clinical benefits,1,2 current approaches to treat patients with obesity are not providing patients with the interventions needed to routinely see this change. One potential solution to this problem is utilizing personalized health planning (PHP) shared medical appointments (SMAs) to address the treatment of obesity. As PHP SMA has shown to improve clinical outcomes and patient satisfaction when compared to traditional care in other chronic illnesses,3,4 it could also be useful as a strategy to improve the efficiency and effectiveness of treating patients with obesity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Feb 2020

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

Study Start

First participant enrolled

February 19, 2020

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 9, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2022

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

July 11, 2023

Completed
Last Updated

March 24, 2026

Status Verified

November 1, 2023

Enrollment Period

1.9 years

First QC Date

December 9, 2021

Last Update Submit

March 20, 2026

Conditions

Keywords

personalized health planningshared medical appointments

Outcome Measures

Primary Outcomes (1)

  • weight change

    tracked over the duration of the study for each participant and the effectiveness of the intervention will be determined by reductions in patients' post-intervention weight and percent weight loss.

    within Seven Months

Secondary Outcomes (4)

  • change in blood pressure

    within seven months

  • Change in waist circumferences

    within seven months

  • Depression

    within seven months

  • change in glycated hemoglobin percentage( A1C)

    within seven months

Study Arms (1)

Cohort

EXPERIMENTAL

Cohort

Behavioral: PHPBehavioral: SMA

Interventions

PHPBEHAVIORAL

personalized health planning (PHP)

Cohort
SMABEHAVIORAL

shared medical appointments (SMAs)

Cohort

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Current patients enrolled at the Methodist Charlton Family Medicine Clinic in Dallas, TX.
  • Female and male patients will be selected based on individual provider recommendations within the Family Medicine Clinic at Methodist Charlton Medical Center (Dallas, TX)
  • Patients will include motivated adults in our clinic from the ages of 30 to 60 yrs old with BMI ranges of 35 to 50 without significant mood or cardio-pulmonary issues.
  • If a patient does have diabetes mellitus (DM), it needs to be under reasonable control (i.e., A1C less than 9).

You may not qualify if:

  • uncontrolled depression with a Patient Health Questionnaire-9(PHQ-9) score greater than 9
  • history of bariatric surgery or future plans for bariatric surgery
  • wheelchair bound
  • uncontrolled chronic obstructive pulmonary disease (COPD)/asthma or supplemental oxygen dependence
  • uncontrolled congestive heart failure (CHF)
  • uncontrolled DM with A1C greater than 9
  • pregnancy
  • active cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Methodist Charlton Family Medicine

Dallas, Texas, 75237, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Khadija Kabani, DO

    Methodist Charlton Family Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2021

First Posted

July 11, 2023

Study Start

February 19, 2020

Primary Completion

January 25, 2022

Study Completion

January 25, 2022

Last Updated

March 24, 2026

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations