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Clinical Trials/NCT05141084
NCT05141084
Unknown
Early Phase 1

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

University of Arizona0 sites40 target enrollmentDecember 1, 2021
ConditionsObesity

Overview

Phase
Early Phase 1
Intervention
Not specified
Conditions
Obesity
Sponsor
University of Arizona
Enrollment
40
Primary Endpoint
Waist circumference
Last Updated
4 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2021
End Date
July 30, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ambereen Ahmed

Integrative Medicine Fellow and Junior Faculty

University of Arizona

Eligibility Criteria

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

Waist circumference

Time Frame: through study completion, anticipated 6 months

Weight

Time Frame: through study completion, anticipated 6 months

Body fat percentage

Time Frame: through study completion, anticipated 6 months

Secondary Outcomes

  • Systolic and diastolic blood pressure(through study completion, anticipated 6 months)
  • Cholesterol(through study completion, anticipated 6 months)
  • Generalized Anxiety Disorder-7(through study completion, anticipated 6 months)
  • Hemoglobin a1c(through study completion, anticipated 6 months)
  • Patient Health Questionnaire-9(through study completion, anticipated 6 months)

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