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

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

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

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.

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.

Weight Loss, Diet Modification, Body Weight, Body Weight Changes, Ketogenic diet, Diet, Carbohydrate-Restricted, Fasting, Intermittent Fasting, Hunger training

Participants monitor their hunger symptoms and blood glucose, and eat only when blood glucose is below a certain threshold level.

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

Feasibility of retaining participants in a randomized dietary intervention in a clinic setting as measured by the number of participants completing all study visits

Feasibility of maintaining participant adherence in a randomized dietary intervention in a clinic setting will be measured by attendance at scheduled clinic visits

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.

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