Weight Loss in Primary Care With Targeted Education and Frequent Follow Ups
Primary Purpose
Obesity
Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Education, lifestyle
Sponsored by
About this trial
This is an interventional treatment trial for Obesity
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
Sites / Locations
Outcomes
Primary Outcome Measures
Weight
Waist circumference
Body fat percentage
Secondary Outcome Measures
Systolic and diastolic blood pressure
Hemoglobin a1c
Cholesterol
Patient Health Questionnaire-9
Measure of depression, maximum score of 27 indicating severe depression, minimum score of 0 indicating likely no depression
Generalized Anxiety Disorder-7
Measure of anxiety, maximum score of 21 indicating severe anxiety, minimum score of 0 meaning likely no anxiety
Full Information
NCT ID
NCT05141084
First Posted
November 6, 2021
Last Updated
November 18, 2021
Sponsor
University of Arizona
1. Study Identification
Unique Protocol Identification Number
NCT05141084
Brief Title
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
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2021 (Anticipated)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
July 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Arizona
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Education, lifestyle
Intervention Description
The weight loss program itself is the intervention, which will involve lifestyle modifications and intervention.
Primary Outcome Measure Information:
Title
Weight
Time Frame
through study completion, anticipated 6 months
Title
Waist circumference
Time Frame
through study completion, anticipated 6 months
Title
Body fat percentage
Time Frame
through study completion, anticipated 6 months
Secondary Outcome Measure Information:
Title
Systolic and diastolic blood pressure
Time Frame
through study completion, anticipated 6 months
Title
Hemoglobin a1c
Time Frame
through study completion, anticipated 6 months
Title
Cholesterol
Time Frame
through study completion, anticipated 6 months
Title
Patient Health Questionnaire-9
Description
Measure of depression, maximum score of 27 indicating severe depression, minimum score of 0 indicating likely no depression
Time Frame
through study completion, anticipated 6 months
Title
Generalized Anxiety Disorder-7
Description
Measure of anxiety, maximum score of 21 indicating severe anxiety, minimum score of 0 meaning likely no anxiety
Time Frame
through study completion, anticipated 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Weight Loss in Primary Care With Targeted Education and Frequent Follow Ups
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