ObesityLIHTNCT03998878
Testing the Effect of Multiple Weight Management Modalities for Chronic Disease Risk Reduction in a Clinical Setting
A study testing Low-Carbohydrate Diet, Intermittent Energy Restriction and Hunger Training in people with Obesity, run by University of Arizona at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Low-Carbohydrate Diet, Intermittent Energy Restriction and Hunger Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2019to 16 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Overweight/obese as indicated by BMI >27
- Age ≥ 18
- HbA1C <8.0
- Fluent in English
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Low-Carbohydrate Diet, Intermittent Energy Restriction, Hunger Training
- Keywords
- Weight Loss, Diet Modification, Body Weight, Body Weight Changes, Ketogenic diet, Diet, Carbohydrate-Restricted, Fasting, Intermittent Fasting, Hunger training
- Medical subject headings
- Obesity, Weight Loss, Body Weight, Body Weight Changes, Fasting, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Carbohydrate DietBehavioural
Participants will be instructed to follow a low-carbohydrate diet.
Intermittent Energy RestrictionBehavioural
Participants will be instructed to follow intermittent energy restriction.
Hunger TrainingBehavioural
Participants will be instructed to follow Hunger Training.
| Study group | Role | What they receive |
|---|---|---|
| Low-Carbohydrate Diet | Experimental | Participants will be instructed to consume less than 30 grams of carbohydrates per day. Receives: Behavioral: Low-Carbohydrate Diet |
| Intermittent Energy Restriction | Experimental | Participants choose 2 non-consecutive days per week in which they will consume 500-650 calories. Receives: Behavioral: Intermittent Energy Restriction |
| Hunger Training | Experimental | Participants monitor their hunger symptoms and blood glucose, and eat only when blood glucose is below a certain threshold level. Receives: Behavioral: Hunger Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 1 year
Change in Weight
Participant weight will be measured
Measured: baseline to 3 months
Change in BMI
Participant BMI will be measured
Measured: baseline to 3 months
Change in HbA1c
Participant HbA1c will be measured
Measured: baseline to 3 months
Change in Fasting Glucose
Participant fasting glucose will be measured
Measured: baseline to 3 months
Change in Fasting Insulin
Participant fasting insulin will be measured
Measured: baseline to 3 months
Change in Total Cholesterol
Participant total cholesterol will be measured
Measured: baseline to 3 months
Change in Triglycerides
Participant triglycerides will be measured
Measured: baseline to 3 months
Change in High Density Lipoprotein (HDL)
Participant HDL will be measured
Measured: baseline to 3 months
Change in Low Density Lipoprotein (LDL)
Participant LDL will be measured
Measured: baseline to 3 months
Change in C-Reactive Protein (CRP)
Participant CRP will be measured
Measured: baseline to 3 months
Change in Insulin-like Growth Factor 1 (IGF-1)
Participant IGF-1 will be measured
Measured: baseline to 3 months
Change in Insulin-like Growth Factor 2 (IGF-2)
Participant IGF-2 will be measured
Measured: baseline to 3 months
Change in Insulin-like Growth Factor Binding Protein 3 (IGFBP-3)
Participant IGFBP-3 will be measured
Measured: baseline to 3 months
Change in Leptin
Participant leptin will be measured
Measured: baseline to 3 months
Change in Adiponectin
Participant adiponectin will be measured
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start8 Aug 2019
- Primary completion16 Dec 2021
- Study completion16 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amit Algotar, MD, PhD, MPH, Principal investigator, University of Arizona, Banner University Medical CenterSusan M Schembre, PhD, RD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03998878
- Sponsor's protocol ID
- 1903480167
- Acronym
- LIHT
- Status last verified
- Dec 2021
- First submitted
- 24 Jun 2019
- Last updated
- 17 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Effect of Multiple Weight Management Modalities for Chronic Disease Risk Reduction in a Clinical Setting (LIHT)
- ClinicalTrials.gov ID
- NCT03998878
- Acronym / sponsor ID
- LIHT / 1903480167
- Conditions
- Obesity
- Keywords
- Weight Loss, Diet Modification, Body Weight, Body Weight Changes, Ketogenic diet, Diet, Carbohydrate-Restricted, Fasting, Intermittent Fasting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 8 Aug 2019 (actual)
- Primary completion
- 16 Dec 2021 (actual)
- Study completion
- 16 Dec 2021 (actual)
- First posted
- 26 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-Carbohydrate Diet | Experimental | Behavioral: Low-Carbohydrate DietParticipants will be instructed to consume less than 30 grams of carbohydrates per day. |
| Intermittent Energy Restriction | Experimental | Behavioral: Intermittent Energy RestrictionParticipants choose 2 non-consecutive days per week in which they will consume 500-650 calories. |
| Hunger Training | Experimental | Behavioral: Hunger TrainingParticipants monitor their hunger symptoms and blood glucose, and eat only when blood glucose is below a certain threshold level. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Overweight/obese as indicated by BMI >27
- Age ≥ 18
- HbA1C <8.0
- Fluent in English
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-Carbohydrate DietParticipants will be instructed to follow a low-carbohydrate diet. | Behavioural | Low-Carbohydrate Diet |
| Intermittent Energy RestrictionParticipants will be instructed to follow intermittent energy restriction. | Behavioural | Intermittent Energy Restriction |
| Hunger TrainingParticipants will be instructed to follow Hunger Training. | Behavioural | Hunger Training |
Primary outcome
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
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
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
Change in Weight
Time frame: baseline to 3 months
Participant weight will be measured
Change in BMI
Time frame: baseline to 3 months
Participant BMI will be measured
Change in HbA1c
Time frame: baseline to 3 months
Participant HbA1c will be measured
Change in Fasting Glucose
Time frame: baseline to 3 months
Participant fasting glucose will be measured
Change in Fasting Insulin
Time frame: baseline to 3 months
Participant fasting insulin will be measured
Change in Total Cholesterol
Time frame: baseline to 3 months
Participant total cholesterol will be measured
Change in Triglycerides
Time frame: baseline to 3 months
Participant triglycerides will be measured
Change in High Density Lipoprotein (HDL)
Time frame: baseline to 3 months
Participant HDL will be measured
Change in Low Density Lipoprotein (LDL)
Time frame: baseline to 3 months
Participant LDL will be measured
Change in C-Reactive Protein (CRP)
Time frame: baseline to 3 months
Participant CRP will be measured
Change in Insulin-like Growth Factor 1 (IGF-1)
Time frame: baseline to 3 months
Participant IGF-1 will be measured
Change in Insulin-like Growth Factor 2 (IGF-2)
Time frame: baseline to 3 months
Participant IGF-2 will be measured
Change in Insulin-like Growth Factor Binding Protein 3 (IGFBP-3)
Time frame: baseline to 3 months
Participant IGFBP-3 will be measured
Change in Leptin
Time frame: baseline to 3 months
Participant leptin will be measured
Change in Adiponectin
Time frame: baseline to 3 months
Participant adiponectin will be measured
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amit Algotar, MD, PhD, MPH principal investigator
University of Arizona, Banner University Medical Center
Susan M Schembre, PhD, RD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Carbohydrate Diet, Intermittent Energy Restriction and Hunger Training in people with Obesity, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Recruitment (time frame: 1 year). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2021.