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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05141084
• Other study ID #: aahmed1
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: December 1, 2021
• Est. completion date: July 30, 2022

Study information

• Verified date: November 2021
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: July 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Other:
• Education, lifestyle
The weight loss program itself is the intervention, which will involve lifestyle modifications and intervention.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight		through study completion, anticipated 6 months
Primary	Waist circumference		through study completion, anticipated 6 months
Primary	Body fat percentage		through study completion, anticipated 6 months
Secondary	Systolic and diastolic blood pressure		through study completion, anticipated 6 months
Secondary	Hemoglobin a1c		through study completion, anticipated 6 months
Secondary	Cholesterol		through study completion, anticipated 6 months
Secondary	Patient Health Questionnaire-9	Measure of depression, maximum score of 27 indicating severe depression, minimum score of 0 indicating likely no depression	through study completion, anticipated 6 months
Secondary	Generalized Anxiety Disorder-7	Measure of anxiety, maximum score of 21 indicating severe anxiety, minimum score of 0 meaning likely no anxiety	through study completion, anticipated 6 months