ObesityNCT01862796
Predicting Adherence to a Heart-Healthy Diet in Lean and Obese Individuals
A study testing Underfeeding diet and Weight maintaining diet in people with Obesity and Overweight, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
Background: Sticking to a diet plan can be difficult, but is important for many different health reasons. Some people seem to have a harder time following and sticking to a diet plan than others. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Underfeeding diet and Weight maintaining diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2013to 22 May 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Candidates will be screened by phone to exclude those with BMI greater than or equal to 26 kg/m(2) and BMI less than or equal to 29 kg/m(2), significant health problems, including cancer, hypertension, diabetes, current and past 3-month use of certain prescribed medications, especially those that could affect body weight, such as antidepressants and stimulants as well as smoking, or excess alcohol (greater than 3 drinks/d). Women must not be pregnant or lactating, and be at least 1 year postpartum. Candidates with a history of psychotic disorder or hospitalization for psychiatric illness within the past 1 year will not be eligible. They will need to be weight stable for the past 3 months (plus or minus 2 percent) and cannot be in treatment for obesity or currently receiving psychotherapy. Individuals who meet criteria according to the phone screen will be invited to come to the unit for a screening visit and their screening sheets are placed in a locked filing cabinet. Forms from potential volunteers who are ineligible are shredded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Non-Adherence Unique to Weight-Loss? Predictors of Adherence to a Heart-Healthy Diet in Lean vs. Obese Individuals
Background:
- Sticking to a diet plan can be difficult, but is important for many different health reasons. Some people seem to have a harder time following and sticking to a diet plan than others. It is not clear whether people of different weights (lean or obese) might have differences in the way they adhere to diet plans. Researchers want to study three different groups of people based on their body mass index (BMI), which measures people based on their weight and height. The study will place the participants on a 6-week diet and see how well they follow the diet. The information from this study may help develop better weight-loss plans and healthy diet ideas.
Read more
Objectives:
- To understand what factors affect adherence to a diet plan.
- To collect information for future studies that may improve people's ability to stick to diets.
Eligibility:
- Individuals at least 18 years of age who are lean (BMI between 18.5 and 25) or obese (BMI greater than 30).
Design:
- Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. They will have a full-body scan to measure fat and muscle. They will also answer questions on eating behaviors, mood, and desire to change eating patterns.
- Participants will be separated into three groups. Each group will have a different diet. The lean group will have a heart-healthy diet designed to maintain the same weight. One of the obese groups will also have a heart-healthy diet designed to maintain the same weight. The other obese group will have a heart-healthy weight loss diet. In all groups, all food will be provided by the study doctors. Participants should not eat any food other than that provided for the study.
- Everyone will start with a 1-week food testing period to find the right number of calories for each group. After this first week, participants will attend one diet counseling session per week and will be contacted randomly once a week to check on the foods they have had in the past 24 hours. Participants will complete daily food diaries on paper as well as daily food records using a smart phone.
- Participants will come to the clinic twice a week to pick up the diet food. On one of those days, they will also have their counseling session.
- The study will last for 6 weeks. At the final study visit, participants will repeat the tests from the screening study.
Read the detailed description
Adherence, or "sticking to your diet" is important for successful initial weight loss and keeping off the weight over the long term (1). While early behavioral and dietary adherence have been associated with greater weight loss, sticking to a diet plan is difficult. It is not clear if adherence to any diet plan (even one which does not produce weight loss) is hard or whether people who are overweight have more difficulty with adhering to diet plans compared to people who are relatively lean.
The main aim of this study is to evaluate dietary adherence in 3 groups of individuals participating in a 6-week heart-healthy dietary intervention program. Two groups [1 (BMI < 25 kg/m(2)) and 2. Obese (BMI greater than or equal to 30 kg/m(2))] will receive a heart-healthy diet designed to maintain their weight, and the third group [3. Obese] will be given a heart-healthy diet that is 35% less than their daily calorie needs to lose weight. Participants will attend one counseling session per week and will be contacted randomly 1x/week by study staff for completion of a 24-hour dietary recall. They will complete daily food diaries and daily records using smart-phones. Prior to starting the assigned heart-healthy dietary intervention, participants will complete questionnaires that include questions about how motivated they are to follow a diet, lose weight, and change eating patterns. These findings may help us understand what factors affect adherence, and help us design weight loss studies that improve people's ability to stick to diet interventions.
- Conditions
- Obesity, Overweight
- Being tested
- Underfeeding diet, Weight maintaining diet
- Keywords
- Food Intake, Weight Loss, Compliance
- Medical subject headings
- Obesity, Overweight, Weight Loss, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Underfeeding dietBehavioural
Also called UF
Heart healthy diet with 35% reduced calories
Weight maintaining dietBehavioural
Also called WMEN
Heart healthy weight-maintaining diet
| Study group | Role | What they receive |
|---|---|---|
| Obese underfeeding (UF) | Experimental | Obese randomized to received a 35% calorie reduced diet Receives: Behavioral: Underfeeding diet |
| Obese weight maintaining (WMEN) | Experimental | Randomized to receive a weight-maintaining diet Receives: Behavioral: Weight maintaining diet |
| Lean weight maintaining (WMEN) | Experimental | Normal weight individuals receiving a weight-maintaining energy needs diet Receives: Behavioral: Weight maintaining diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence Score
An adherence score is calculated each week by summing 7 measurements of adherence and dividing by 21, the maximum score, with range from 0 (no adherence) to 1 (perfectly adherent). For each of the 7 measures a higher score means better adherence: [1] Attendance (0-2), [2] Food diaries (0-3), [3] 24-hour food recall via interview (0-3), [4] computer survey (0-3), [5] 24-hour food recall via interview (0-3), [6] Ecological momentary assessment (0-6), and [7] On time arrival for session (0-1). The final score is calculated as the average of the six weekly scores.
Measured: Average over 6 weeks
Secondary outcomes (1)
Change in Weight From Baseline to 6 Weeks
Weight loss from baseline, calculated as weight at 6 weeks - weight at baseline
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2013 (estimated)
- Study start31 May 2013
- Primary completion22 May 2018
- Study completion22 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- 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
- 100 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Marci Gluck, Ph.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01862796
- Sponsor's protocol ID
- 999913096
- Other IDs
- 13-DK-N096
- Status last verified
- 22 May 2018
- First submitted
- 23 May 2013
- Last updated
- 15 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Fappa E, Yannakoulia M, Pitsavos C, Skoumas I, Valourdou S, Stefanadis C. Lifestyle intervention in the management of metabolic syndrome: could we improve adherence issues? Nutrition. 2008 Mar;24(3):286-91. doi: 10.1016/j.nut.2007.11.008. Epub 2008 Jan 16.
PubMed 18201869Flegal KM, Graubard BI, Williamson DF, Gail MH. Weight-associated deaths in the United States. J Womens Health (Larchmt). 2007 Nov;16(9):1368-70. doi: 10.1089/jwh.2007.0547. No abstract available.
PubMed 18001195Kassirer JP, Angell M. Losing weight--an ill-fated New Year's resolution. N Engl J Med. 1998 Jan 1;338(1):52-4. doi: 10.1056/NEJM199801013380109. No abstract available.
PubMed 9414332Stinson EJ, Piaggi P, Votruba SB, Venti C, Lovato-Morales B, Engel S, Krakoff J, Gluck ME. Is Dietary Nonadherence Unique to Obesity and Weight Loss? Results From a Randomized Clinical Trial. Obesity (Silver Spring). 2020 Nov;28(11):2020-2027. doi: 10.1002/oby.23008.
PubMed 32808484
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Non-Adherence Unique to Weight-Loss? Predictors of Adherence to a Heart-Healthy Diet in Lean vs. Obese Individuals
- ClinicalTrials.gov ID
- NCT01862796
- Acronym / sponsor ID
- 999913096
- Conditions
- Obesity, Overweight
- Keywords
- Food Intake, Weight Loss, Compliance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 31 May 2013
- Primary completion
- 22 May 2018 (actual)
- Study completion
- 22 May 2018 (actual)
- First posted
- 24 May 2013 (estimated)
- Results
- Posted 15 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- Sticking to a diet plan can be difficult, but is important for many different health reasons. Some people seem to have a harder time following and sticking to a diet plan than others. It is not clear whether people of different weights (lean or obese) might have differences in the way they adhere to diet plans. Researchers want to study three different groups of people based on their body mass index (BMI), which measures people based on their weight and height. The study will place the participants on a 6-week diet and see how well they follow the diet. The information from this study may help develop better weight-loss plans and healthy diet ideas.
Objectives:
- To understand what factors affect adherence to a diet plan.
- To collect information for future studies that may improve people's ability to stick to diets.
Eligibility:
- Individuals at least 18 years of age who are lean (BMI between 18.5 and 25) or obese (BMI greater than 30).
Design:
- Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. They will have a full-body scan to measure fat and muscle. They will also answer questions on eating behaviors, mood, and desire to change eating patterns.
- Participants will be separated into three groups. Each group will have a different diet. The lean group will have a heart-healthy diet designed to maintain the same weight. One of the obese groups will also have a heart-healthy diet designed to maintain the same weight. The other obese group will have a heart-healthy weight loss diet. In all groups, all food will be provided by the study doctors. Participants should not eat any food other than that provided for the study.
- Everyone will start with a 1-week food testing period to find the right number of calories for each group. After this first week, participants will attend one diet counseling session per week and will be contacted randomly once a week to check on the foods they have had in the past 24 hours. Participants will complete daily food diaries on paper as well as daily food records using a smart phone.
- Participants will come to the clinic twice a week to pick up the diet food. On one of those days, they will also have their counseling session.
- The study will last for 6 weeks. At the final study visit, participants will repeat the tests from the screening study.
Detailed description
Adherence, or "sticking to your diet" is important for successful initial weight loss and keeping off the weight over the long term (1). While early behavioral and dietary adherence have been associated with greater weight loss, sticking to a diet plan is difficult. It is not clear if adherence to any diet plan (even one which does not produce weight loss) is hard or whether people who are overweight have more difficulty with adhering to diet plans compared to people who are relatively lean.
The main aim of this study is to evaluate dietary adherence in 3 groups of individuals participating in a 6-week heart-healthy dietary intervention program. Two groups [1 (BMI < 25 kg/m(2)) and 2. Obese (BMI greater than or equal to 30 kg/m(2))] will receive a heart-healthy diet designed to maintain their weight, and the third group [3. Obese] will be given a heart-healthy diet that is 35% less than their daily calorie needs to lose weight. Participants will attend one counseling session per week and will be contacted randomly 1x/week by study staff for completion of a 24-hour dietary recall. They will complete daily food diaries and daily records using smart-phones. Prior to starting the assigned heart-healthy dietary intervention, participants will complete questionnaires that include questions about how motivated they are to follow a diet, lose weight, and change eating patterns. These findings may help us understand what factors affect adherence, and help us design weight loss studies that improve people's ability to stick to diet interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Obese underfeeding (UF) | Experimental | Behavioral: Underfeeding dietObese randomized to received a 35% calorie reduced diet |
| Obese weight maintaining (WMEN) | Experimental | Behavioral: Weight maintaining dietRandomized to receive a weight-maintaining diet |
| Lean weight maintaining (WMEN) | Experimental | Behavioral: Weight maintaining dietNormal weight individuals receiving a weight-maintaining energy needs diet |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Candidates will be screened by phone to exclude those with BMI greater than or equal to 26 kg/m(2) and BMI less than or equal to 29 kg/m(2), significant health problems, including cancer, hypertension, diabetes, current and past 3-month use of certain prescribed medications, especially those that could affect body weight, such as antidepressants and stimulants as well as smoking, or excess alcohol (greater than 3 drinks/d). Women must not be pregnant or lactating, and be at least 1 year postpartum. Candidates with a history of psychotic disorder or hospitalization for psychiatric illness within the past 1 year will not be eligible. They will need to be weight stable for the past 3 months (plus or minus 2 percent) and cannot be in treatment for obesity or currently receiving psychotherapy. Individuals who meet criteria according to the phone screen will be invited to come to the unit for a screening visit and their screening sheets are placed in a locked filing cabinet. Forms from potential volunteers who are ineligible are shredded.
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 |
|---|---|---|
| Underfeeding dietAlso: UFHeart healthy diet with 35% reduced calories | Behavioural | Obese underfeeding (UF) |
| Weight maintaining dietAlso: WMENHeart healthy weight-maintaining diet | Behavioural | Lean weight maintaining (WMEN), Obese weight maintaining (WMEN) |
Primary outcome
Adherence Score
Time frame: Average over 6 weeks
An adherence score is calculated each week by summing 7 measurements of adherence and dividing by 21, the maximum score, with range from 0 (no adherence) to 1 (perfectly adherent). For each of the 7 measures a higher score means better adherence: [1] Attendance (0-2), [2] Food diaries (0-3), [3] 24-hour food recall via interview (0-3), [4] computer survey (0-3), [5] 24-hour food recall via interview (0-3), [6] Ecological momentary assessment (0-6), and [7] On time arrival for session (0-1). The final score is calculated as the average of the six weekly scores.
1 secondary outcome
Change in Weight From Baseline to 6 Weeks
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18201869Fappa E, Yannakoulia M, Pitsavos C, Skoumas I, Valourdou S, Stefanadis C. Lifestyle intervention in the management of metabolic syndrome: could we improve adherence issues? Nutrition. 2008 Mar;24(3):286-91. doi: 10.1016/j.nut.2007.11.008. Epub 2008 Jan 16.
- Background: PubMed 18001195Flegal KM, Graubard BI, Williamson DF, Gail MH. Weight-associated deaths in the United States. J Womens Health (Larchmt). 2007 Nov;16(9):1368-70. doi: 10.1089/jwh.2007.0547. No abstract available.
- Background: PubMed 9414332Kassirer JP, Angell M. Losing weight--an ill-fated New Year's resolution. N Engl J Med. 1998 Jan 1;338(1):52-4. doi: 10.1056/NEJM199801013380109. No abstract available.
- Derived from this study: PubMed 32808484Stinson EJ, Piaggi P, Votruba SB, Venti C, Lovato-Morales B, Engel S, Krakoff J, Gluck ME. Is Dietary Nonadherence Unique to Obesity and Weight Loss? Results From a Randomized Clinical Trial. Obesity (Silver Spring). 2020 Nov;28(11):2020-2027. doi: 10.1002/oby.23008.
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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.
Marci Gluck, Ph.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Underfeeding diet and Weight maintaining diet in people with Obesity and Overweight, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 0 inclusion and 1 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 15 Aug 2019. 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?
Yes. Results are posted in the registry (first posted 15 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Adherence Score (time frame: Average over 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01862796, which also lists 4 linked publications.
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 15 Aug 2019.