Testing the Effect of Multiple Weight Management Modalities for Chronic Disease Risk Reduction in a Clinical Setting

Study Overview
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Brief Summary
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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
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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.

Official Title
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Testing the Effect of Multiple Weight Management Modalities for Chronic Disease Risk Reduction in a Clinical Setting (LIHT)

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Low-Carbohydrate Diet
* Behavioral: Intermittent Energy Restriction
* Behavioral: Hunger Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Overweight/obese as indicated by BMI >27 Age ≥ 18 HbA1C <8.0 Fluent in English Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-Carbohydrate Diet<br>Participants will be instructed to consume less than 30 grams of carbohydrates per day. | Behavioral: Low-Carbohydrate Diet<br>* Participants will be instructed to follow a low-carbohydrate diet.<br>|
| Experimental: Intermittent Energy Restriction<br>Participants choose 2 non-consecutive days per week in which they will consume 500-650 calories. | Behavioral: Intermittent Energy Restriction<br>* Participants will be instructed to follow intermittent energy restriction.<br>|
| Experimental: Hunger Training<br>Participants monitor their hunger symptoms and blood glucose, and eat only when blood glucose is below a certain threshold level. | Behavioral: Hunger Training<br>* Participants will be instructed to follow Hunger Training.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Recruitment | 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 | 1 year | 
| Rate of Retention | Feasibility of retaining participants in a randomized dietary intervention in a clinic setting as measured by the number of participants completing all study visits | 1 year | 
| Adherence to the Intervention | Feasibility of maintaining participant adherence in a randomized dietary intervention in a clinic setting will be measured by attendance at scheduled clinic visits | 1 year | 
| Change in Weight | Participant weight will be measured | baseline to 3 months | 
| Change in BMI | Participant BMI will be measured | baseline to 3 months | 
| Change in HbA1c | Participant HbA1c will be measured | baseline to 3 months | 
| Change in Fasting Glucose | Participant fasting glucose will be measured | baseline to 3 months | 
| Change in Fasting Insulin | Participant fasting insulin will be measured | baseline to 3 months | 
| Change in Total Cholesterol | Participant total cholesterol will be measured | baseline to 3 months | 
| Change in Triglycerides | Participant triglycerides will be measured | baseline to 3 months | 
| Change in High Density Lipoprotein (HDL) | Participant HDL will be measured | baseline to 3 months | 
| Change in Low Density Lipoprotein (LDL) | Participant LDL will be measured | baseline to 3 months | 
| Change in C-Reactive Protein (CRP) | Participant CRP will be measured | baseline to 3 months | 
| Change in Insulin-like Growth Factor 1 (IGF-1) | Participant IGF-1 will be measured | baseline to 3 months | 
| Change in Insulin-like Growth Factor 2 (IGF-2) | Participant IGF-2 will be measured | baseline to 3 months | 
| Change in Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) | Participant IGFBP-3 will be measured | baseline to 3 months | 
| Change in Leptin | Participant leptin will be measured | baseline to 3 months | 
| Change in Adiponectin | Participant adiponectin will be measured | baseline to 3 months | 
| Participant Satisfaction | 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. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weight Loss, Diet Modification, Body Weight, Body Weight Changes, Ketogenic diet, Diet, Carbohydrate-Restricted, Fasting, Intermittent Fasting, Hunger training