Clinical trial NCT05141084: Weight Loss in Primary Care With Targeted Education and Frequent Follow Ups
Official title: Weight Loss in Primary Care With Targeted Education and Frequent Follow Ups
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Obesity
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2021-12-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Weight
timeFrame: through study completion, anticipated 6 months
measure: Waist circumference
timeFrame: through study completion, anticipated 6 months
measure: Body fat percentage
timeFrame: through study completion, anticipated 6 months
Secondary outcomes:
measure: Systolic and diastolic blood pressure
timeFrame: through study completion, anticipated 6 months
measure: Hemoglobin a1c
timeFrame: through study completion, anticipated 6 months
measure: Cholesterol
timeFrame: through study completion, anticipated 6 months
measure: Patient Health Questionnaire-9
timeFrame: through study completion, anticipated 6 months
measure: Generalized Anxiety Disorder-7
timeFrame: through study completion, anticipated 6 months
Other outcomes:
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