Testing the Effect of Multiple Weight Management Modalities for Chronic Disease Risk Reduction in a Clinical Setting
- Conditions
- Obesity
- Interventions
- Behavioral: Intermittent Energy RestrictionBehavioral: Hunger TrainingBehavioral: Low-Carbohydrate Diet
- Registration Number
- NCT03998878
- Lead Sponsor
- University of Arizona
- Brief Summary
This project will test 3 methods of dietary changes in a weight loss clinic. Participants will be randomized to one of 3 arms: low-carbohydrate diet, intermittent energy restriction, or Hunger Training. A maximum of 30 participants will be assigned to each arm. The goal of the proposed study is to determine the feasibility, early efficacy, and patient satisfaction of each weight loss modality in a population of patients seeking care at a weight loss clinic.
- Detailed Description
Adult obesity, a common condition in the United States, is a well-established risk factor for the development of chronic diseases, including diabetes, heart disease, hypertension, and many types of cancer. However, research has not determined what type of diet is best for reducing weight and achieving optimal health outcomes. In this randomized trial, participants seeking care at a weight loss clinic will be assigned to one of three diets: low-carbohydrate, intermittent energy restriction, or Hunger Training. On the low-carbohydrate diet, participants will be instructed to consume less than 30 grams of carbohydrates per day. The intermittent energy restriction protocol will require participants to choose 2 non-consecutive days per week in which they will consume 500-650 calories. Hunger Training is a relatively new approach that involves teaching people to monitor their hunger symptoms and blood glucose, and to eat only when blood glucose is below a certain level. To our knowledge, these weight loss modalities have not been compared in a single, clinical study. The goal of the proposed study is to determine the feasibility, early efficacy, and patient satisfaction of each weight loss modality in a population of patients seeking care at a weight loss clinic. The goal will be achieved though the successful completion of the following aims:
Aim 1: To determine the feasibility of recruiting, retaining and maintaining the adherence participants in a randomized clinical trial testing 3 weight loss modalities.
Aim 2: To examine and compare the effect of 3 weight loss modalities on changes in anthropometric measures and metabolic and cancer-related health markers.
Aim 3: To evaluate and compare patients' perceived satisfaction with each weight loss modality.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 9
- Overweight/obese as indicated by BMI >27
- Age ≥ 18
- HbA1C <8.0
- Fluent in English
- Cognitive state that precludes informed consent or adherence to study protocols
- Pregnant, breast-feeding, or planning to become pregnant within 6 months
- A1C ≥ 8.0
- Taking an anti-obesity medication
- Insulin-dependence
- prior metabolic surgery
- current laparoscopic adjustable gastric band ("lap band") use
- Experience of substantial weight changes (±5 kg or ±10 lbs) in the past 3 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intermittent Energy Restriction Intermittent Energy Restriction Participants choose 2 non-consecutive days per week in which they will consume 500-650 calories. Hunger Training Hunger Training Participants monitor their hunger symptoms and blood glucose, and eat only when blood glucose is below a certain threshold level. Low-Carbohydrate Diet Low-Carbohydrate Diet Participants will be instructed to consume less than 30 grams of carbohydrates per day.
- Primary Outcome Measures
Name Time Method Rate of Retention 1 year Feasibility of retaining participants in a randomized dietary intervention in a clinic setting as measured by the number of participants completing all study visits
Change in BMI baseline to 3 months Participant BMI will be measured
Change in C-Reactive Protein (CRP) baseline to 3 months Participant CRP will be measured
Change in Fasting Glucose baseline to 3 months Participant fasting glucose will be measured
Change in Low Density Lipoprotein (LDL) baseline to 3 months Participant LDL will be measured
Change in Insulin-like Growth Factor 2 (IGF-2) baseline to 3 months Participant IGF-2 will be measured
Change in Adiponectin baseline to 3 months Participant adiponectin will be measured
Rate of Recruitment 1 year Feasibility of recruiting participants into a randomized dietary intervention in a clinic setting as measured by the total number of individuals who are screened as eligible and enrolled into the study
Adherence to the Intervention 1 year Feasibility of maintaining participant adherence in a randomized dietary intervention in a clinic setting will be measured by attendance at scheduled clinic visits
Change in Fasting Insulin baseline to 3 months Participant fasting insulin will be measured
Change in Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) baseline to 3 months Participant IGFBP-3 will be measured
Change in Weight baseline to 3 months Participant weight will be measured
Change in HbA1c baseline to 3 months Participant HbA1c will be measured
Change in High Density Lipoprotein (HDL) baseline to 3 months Participant HDL will be measured
Change in Insulin-like Growth Factor 1 (IGF-1) baseline to 3 months Participant IGF-1 will be measured
Change in Leptin baseline to 3 months Participant leptin will be measured
Change in Total Cholesterol baseline to 3 months Participant total cholesterol will be measured
Change in Triglycerides baseline to 3 months Participant triglycerides will be measured
Participant Satisfaction 3 months Participants will complete a questionnaire at the end of the study to assess the acceptability of and satisfaction with the weight loss diet intervention they received. We will assess overall satisfaction, enjoyment, likeliness to recommend, and ease of following the diet. Aggregated scores will be compared across weight loss modality.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Arizona
🇺🇸Tucson, Arizona, United States