Skip to main content
OpenTrials
Completed

NCT Number: NCT03998878

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity Behavior Body Weight Body Weight Changes Fasting Feeding Behavior Intermittent Fasting Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arizona

Tucson, Arizona, 85714, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low-Carbohydrate Diet

Behavioral

Participants will be instructed to follow a low-carbohydrate diet.

Intermittent Energy Restriction

Behavioral

Participants will be instructed to follow intermittent energy restriction.

Hunger Training

Behavioral

Participants will be instructed to follow Hunger Training.

Primary outcomes

  1. Rate of Recruitment

    Time frame: 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

  2. Rate of Retention

    Time frame: 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

  3. Adherence to the Intervention

    Time frame: 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

  4. Change in Weight

    Time frame: baseline to 3 months

    Participant weight will be measured

  5. Change in BMI

    Time frame: baseline to 3 months

    Participant BMI will be measured

  6. Change in HbA1c

    Time frame: baseline to 3 months

    Participant HbA1c will be measured

  7. Change in Fasting Glucose

    Time frame: baseline to 3 months

    Participant fasting glucose will be measured

  8. Change in Fasting Insulin

    Time frame: baseline to 3 months

    Participant fasting insulin will be measured

  9. Change in Total Cholesterol

    Time frame: baseline to 3 months

    Participant total cholesterol will be measured

  10. Change in Triglycerides

    Time frame: baseline to 3 months

    Participant triglycerides will be measured

  11. Change in High Density Lipoprotein (HDL)

    Time frame: baseline to 3 months

    Participant HDL will be measured

  12. Change in Low Density Lipoprotein (LDL)

    Time frame: baseline to 3 months

    Participant LDL will be measured

  13. Change in C-Reactive Protein (CRP)

    Time frame: baseline to 3 months

    Participant CRP will be measured

  14. Change in Insulin-like Growth Factor 1 (IGF-1)

    Time frame: baseline to 3 months

    Participant IGF-1 will be measured

  15. Change in Insulin-like Growth Factor 2 (IGF-2)

    Time frame: baseline to 3 months

    Participant IGF-2 will be measured

  16. Change in Insulin-like Growth Factor Binding Protein 3 (IGFBP-3)

    Time frame: baseline to 3 months

    Participant IGFBP-3 will be measured

  17. Change in Leptin

    Time frame: baseline to 3 months

    Participant leptin will be measured

  18. Change in Adiponectin

    Time frame: baseline to 3 months

    Participant adiponectin will be measured

  19. Participant Satisfaction

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Registry information

Official study title

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

Acronym: LIHT

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 26, 2019
Registry last updated
Dec 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.