Weight Loss in Primary Care With Targeted Education and Frequent Follow Ups

Sponsor

University of Arizona (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05141084

Collaborator

(none)

Enrollment

7.9

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The investigators will be recruiting patients in the primary care setting to enroll a weight loss program where they will be seen every 2 weeks for 3 months, and then every month for 3 months, and the investigators will implement specific interventions tailored to the patients' needs.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Other: Education, lifestyle	Early Phase 1

Detailed Description

Previous studies have shown that weight loss programs with a multidisciplinary approach in the primary care setting have been more successful in achieving weight loss in overweight and obese patients compared to general recommendations to lose weight. A multidisciplinary approach may include involvement of a dietician and a behavioral psychologist, which the investigators will not be able to replicate in our study. However, some of those studies have also shown that frequent follow-up visits have also been shown to be helpful for weight loss. Frequent follow ups help with weight loss because it helps patients maintain their accountability by giving them realistic goals with measurable deadlines. Education is also an important factor to weight loss, including understanding an individualized dietary and exercise approach. Weight loss in the primary care setting is of great significance because it can offload healthcare costs by reducing the morbidity of disease for a variety of comorbid conditions such as diabetes, hypertension or hyperlipidemia. Studies have shown that exercise alone (without any reduction in weight) improves hypertension and glucose sensitivity in patients. The investigators hypothesize that achieving weight loss will have an additive effect to these health improvements. The American Heart Association recently revised their cholesterol guidelines for reducing atherosclerotic cardiovascular disease (ASCVD) by listing the first and foremost recommendation as: "a healthy lifestyle reduces ASCVD risk at all ages. In all age groups, lifestyle therapy is the primary intervention for metabolic syndrome." So, diet and lifestyle modifications are recognized by many societies as an important and necessary intervention for patients to live healthy lives and decrease the morbidity and mortality associated with disease.

Additionally, overweight and obese people also have a high incidence of chronic joint pains which often result in therapies, invasive joint surgeries, immobility, or chronic treatments with prescription pain medications. It has been shown that these joint pains can be reduced with weight loss preventing the need for those aforementioned therapies which have a high cost burden on the healthcare system. The biggest determining factor of weight loss is a person's adherence to the intervention, which will hope to address with close follow up to hold patient's accountable to their weight loss goals.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Weight Loss in Primary Care With Targeted Education and Frequent Follow Ups

Anticipated Study Start Date :

Dec 1, 2021

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Jul 30, 2022

Outcome Measures

Primary Outcome Measures

Weight [through study completion, anticipated 6 months]
Waist circumference [through study completion, anticipated 6 months]
Body fat percentage [through study completion, anticipated 6 months]

Secondary Outcome Measures

Systolic and diastolic blood pressure [through study completion, anticipated 6 months]
Hemoglobin a1c [through study completion, anticipated 6 months]
Cholesterol [through study completion, anticipated 6 months]
Patient Health Questionnaire-9 [through study completion, anticipated 6 months]
Measure of depression, maximum score of 27 indicating severe depression, minimum score of 0 indicating likely no depression
Generalized Anxiety Disorder-7 [through study completion, anticipated 6 months]
Measure of anxiety, maximum score of 21 indicating severe anxiety, minimum score of 0 meaning likely no anxiety

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

BMI>30
English and Spanish speaking
All ethnicities

Exclusion Criteria:

Those who have had bariatric surgery within the last 1 year or are actively still losing weight from bariatric surgery
Those who are part of another weight loss program
Those who are actively using substances such as drugs or alcohol
Pregnant women
Children

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Arizona

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ambereen Ahmed, Integrative Medicine Fellow and Junior Faculty, University of Arizona

ClinicalTrials.gov Identifier:

NCT05141084

Other Study ID Numbers:

aahmed1

First Posted:

Dec 2, 2021

Last Update Posted:

Dec 2, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Weight Loss

Study Results

No Results Posted as of Dec 2, 2021