ObesityDietChoiceNCT01152359
Considering Patient Diet Preferences to Optimize Weight Loss
A study testing Choice in people with Obesity, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Obesity is increasingly common and can lead to decreased quality of life, increased medical and psychiatric illness, high health care costs, and early mortality. The problem of obesity is as great in veterans as it is in the general public. Read more about this study
- Who is it for?
- Ages Up to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Choice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Aug 2013
- 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 Up to 74 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Body mass index 30 or greater
- Stable health
- Desire to lose weight
- Agrees to attend regular visits
- Access to telephone and reliable transportation
- Has a Veterans Affairs Medical Center (VAMC) provider
Who cannot join
- Certain chronic or unstable disease (kidney or liver disease, type 1 diabetes, hemoglobin A1c 12% or more, insulin use, unstable heart disease, transplant recipient, blood pressure 160/100 or greater, fasting blood triglycerides 600 or greater, LDL cholesterol 190 or greater)
- Pregnancy, breastfeeding, lack of birth control
- Active dementia, psychiatric illness, or substance abuse (past year)
- Weight loss therapy in previous month
- Pacemaker or defibrillator
- Enrolled in another study that might affect measurements
- Previously in study of low-carbohydrate or low-fat diet for weight loss
- Unable to complete all study measures
Trial locations and contacts
1 site in 1 country.
United States1 site
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705
About this study
Official title: Considering Patient Diet Preference to Optimize Weight Loss
Obesity is increasingly common and can lead to decreased quality of life, increased medical and psychiatric illness, high health care costs, and early mortality. The problem of obesity is as great in veterans as it is in the general public. Adherence to dietary therapy for obesity is often inadequate, possibly because patients' food preferences are not considered during dietary counseling. Allowing patients to choose a diet based on their food preferences may increase their motivation to adhere to diet counseling. This, in turn, could enhance their weight loss success and, ultimately, reduce the many health complications and costs of obesity. The proposed study will examine whether assessing a person's food preferences, and then allowing the person to choose from two commonly prescribed diets, results in greater weight loss success.
Read the detailed description
The prevalence of obesity (body mass index [BMI] 30 kg/m2) in US adults has skyrocketed over the past 30 years, and is currently as high or higher in veterans as it is in non-veterans. Thus, identifying effective strategies for treating obesity is both a public health and a VA priority. A variety of diet approaches have proven successful in achieving moderate weight loss in many individuals. Yet, most diet interventions fail to achieve meaningful weight loss in more than a few individuals. This failure likely results from inadequate adherence to the diet.
It is widely felt, but not empirically shown, that targeting the diet to an individual's food preferences will enhance adherence, thereby improving weight loss outcomes. This study will test the commonly proposed assumption that helping patients choose a diet based on their dietary preferences will increase weight loss success relative to assigning or recommending one diet.
The proposed study is a 2-arm randomized controlled trial involving 216 outpatients from Durham VA Medical Center. Participants must be obese (BMI 30 kg/m) VAMC outpatients without unstable health issues. Participants in the experimental arm (Choice) will select from two of the most widely studied diets for weight loss, either a low-carbohydrate, calorie-unrestricted diet (LCD) or a low-fat, reduced-calorie diet (LFD). This choice will be informed by results from a validated food preference questionnaire and a discussion of available diet options with trained personnel. As may occur in the clinical setting, the Choice participants will also have the opportunity to switch to the other diet after 3 months if unsuccessful or dissatisfied with their primary selection. The Choice intervention is designed to enhance the three psychological needs of a person according to self-determination theory (SDT): competence, relatedness, and, in particular, autonomy. This should maximize intrinsic motivation, thereby improving adherence to diet recommendations and increasing weight loss. Participants in the Control arm will be randomly assigned to follow one of the two diets for the duration of follow-up.
All participants will receive diet-appropriate counseling in small group meetings every 2 weeks for 24 weeks, then monthly for another 24 weeks. All participants will also receive brief telephone counseling involving individual goal setting and problem solving halfway through each month in the latter 24 weeks. The primary outcome is weight change from baseline to 48 weeks. Secondary outcomes include adherence to diet by food frequency questionnaire and obesity-specific health-related quality of life. Exploratory analyses will examine whether the impact of choice versus lack of choice on weight loss is moderated by individual differences in the SDT constructs of autonomy orientation, competence, and relatedness.
If assisting patients to choose their diet enhances adherence and increases weight loss, the results will support the provision of diet options to veterans and non-veterans alike, and bring us one step closer to remediating the obesity epidemic faced by the VA and other healthcare systems.
- Conditions
- Obesity
- Being tested
- Choice, Control
- Keywords
- obesity, diet, low carbohydrate, diet, fat-restricted, food preferences, quality of life, patient compliance
- Medical subject headings
- Obesity, Food Preferences, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChoiceBehavioural
Participants are allowed to choose between a low-carbohydrate or a low-fat diet for weight loss after receiving information about these diets and their food preferences (Choice arm). Then they receive counseling on their chosen diet in a small group format. The low-carbohydrate diet limits carbohydrate intake to 20-40 grams/day initially. The low-fat diet restricts saturated fat to below 30% of daily calories and has a 500-1000 calorie deficit. Group sessions are every 2 weeks for 24 weeks then alternate with telephone calls every 2 weeks for 24 weeks. Phone calls focus on goal setting to maximize weight loss. Participants also receive counseling on behavioral techniques and physical activity. Participants in this arm have the option to switch diets at 12 weeks.
ControlBehavioural
Participants are randomly assigned to (rather than getting to choose, as in the experimental arm) a low-carbohydrate or a low-fat diet for weight loss (Control arm). Then they receive counseling on their chosen diet in a small group format. The low-carbohydrate diet limits carbohydrate intake to 20-40 grams/day initially. The low-fat diet restricts saturated fat to below 30% of daily calories and has a 500-1000 calorie deficit. Group sessions are every 2 weeks for 24 weeks then alternate with telephone calls every 2 weeks for 24 weeks. Phone calls focus on goal setting to maximize weight loss. Participants also receive counseling on behavioral techniques and physical activity. Participants in this arm do not have the option to switch diets at 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Participants are allowed to choose between a low-carbohydrate or a low-fat diet for weight loss after receiving information about these diets and their food preferences (Choice arm). Then they receive counseling on their chosen diet in a small group format. The low-carbohydrate diet limits carbohydrate intake to 20-40 grams/day initially. The low-fat diet restricts saturated fat to below 30% of daily calories and has a 500-1000 calorie deficit. Group sessions are every 2 weeks for 24 weeks then alternate with telephone calls every 2 weeks for 24 weeks. Phone calls focus on goal setting to maximize weight loss. Participants also receive counseling on behavioral techniques and physical activity. Participants in this arm have the option to switch diets at 12 weeks. Receives: Behavioral: Choice |
| Arm 2 | Active comparator | Participants are randomly assigned to (rather than getting to choose, as in the experimental arm) a low-carbohydrate or a low-fat diet for weight loss (Control arm). Then they receive counseling on their chosen diet in a small group format. The low-carbohydrate diet limits carbohydrate intake to 20-40 grams/day initially. The low-fat diet restricts saturated fat to below 30% of daily calories and has a 500-1000 calorie deficit. Group sessions are every 2 weeks for 24 weeks then alternate with telephone calls every 2 weeks for 24 weeks. Phone calls focus on goal setting to maximize weight loss. Participants also receive counseling on behavioral techniques and physical activity. Participants in this arm do not have the option to switch diets at 12 weeks. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Body Weight From Baseline to 48 Weeks
Measured: Baseline, 48 weeks
Secondary outcomes (2)
Diet Adherence as Measured by Block Food-frequency Questionnaire (Absolute Percentage Deviation From the Goal Macronutrient Intake--<30% Fat for Low-fat Diet or <10% Carbohydrate for Low-carbohydrate Diet)
Measured: 48 weeks
Change in Obesity-specific Health-related Quality of Life as Measured by Impact Of Weight On Quality Of Life-Lite (IWQOL-Lite) Questionnaire From Baseline to 48 Weeks
change in obesity-specific health-related quality of life as measured by Impact Of Weight On Quality Of Life-Lite (IWQOL-Lite) Questionnaire total score from baseline to 48 weeks Minimum 0 Maximum 100 Higher score means better
Measured: Baseline, 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2010 (estimated)
- Study startMay 2011
- Primary completionMay 2013
- Study completionAug 2013
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 (9)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- William S. Yancy, MD MHS, Principal investigator, Durham VA Medical Center, Durham, NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01152359
- Sponsor's protocol ID
- IIR 09-381
- Acronym
- DietChoice
- Status last verified
- Jan 2019
- First submitted
- 14 Jun 2010
- Last updated
- 12 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
McVay MA, Yancy WS Jr, Vijan S, Van Scoyoc L, Neelon B, Voils CI, Maciejewski ML. Obesity-related health status changes and weight-loss treatment utilization. Am J Prev Med. 2014 May;46(5):465-72. doi: 10.1016/j.amepre.2013.11.018.
PubMed 24745636Yancy WS. Peer Support Significantly Improves Compliance in Veterans with Diabetes. U. S. Medicine. 2012 Nov 20.
Yancy WS Jr, McVay MA, Brinkworth GD. Adherence to diets for weight loss. JAMA. 2013 Dec 25;310(24):2676. doi: 10.1001/jama.2013.282639. No abstract available.
PubMed 24368474McVay MA, Jeffreys AS, King HA, Olsen MK, Voils CI, Yancy WS Jr. The relationship between pretreatment dietary composition and weight loss during a randomised trial of different diet approaches. J Hum Nutr Diet. 2015 Feb;28 Suppl 2:16-23. doi: 10.1111/jhn.12188. Epub 2013 Nov 20.
PubMed 24251378McVay MA, Voils CI, Coffman CJ, Geiselman PJ, Kolotkin RL, Mayer SB, Smith VA, Gaillard L, Turner MJ, Yancy WS Jr. Factors associated with choice of a low-fat or low-carbohydrate diet during a behavioral weight loss intervention. Appetite. 2014 Dec;83:117-124. doi: 10.1016/j.appet.2014.08.023. Epub 2014 Aug 19.
PubMed 25149197Yancy WS Jr, Coffman CJ, Geiselman PJ, Kolotkin RL, Almirall D, Oddone EZ, Mayer SB, Gaillard LA, Turner M, Smith VA, Voils CI. Considering patient diet preference to optimize weight loss: design considerations of a randomized trial investigating the impact of choice. Contemp Clin Trials. 2013 May;35(1):106-16. doi: 10.1016/j.cct.2013.03.002. Epub 2013 Mar 16.
PubMed 23506974Yancy WS Jr, Mayer SB, Coffman CJ, Smith VA, Kolotkin RL, Geiselman PJ, McVay MA, Oddone EZ, Voils CI. Effect of Allowing Choice of Diet on Weight Loss: A Randomized Trial. Ann Intern Med. 2015 Jun 16;162(12):805-14. doi: 10.7326/M14-2358.
PubMed 26075751Yancy WS Jr, McVay MA, Voils CI. Effect of allowing choice of diet on weight loss--in response. Ann Intern Med. 2015 Nov 17;163(10):805-6. doi: 10.7326/L15-5159. No abstract available.
PubMed 26571246McVay MA, Voils CI, Geiselman PJ, Smith VA, Coffman CJ, Mayer S, Yancy WS Jr. Food preferences and weight change during low-fat and low-carbohydrate diets. Appetite. 2016 Aug 1;103:336-343. doi: 10.1016/j.appet.2016.04.035. Epub 2016 Apr 29.
PubMed 27133551
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Considering Patient Diet Preference to Optimize Weight Loss
- ClinicalTrials.gov ID
- NCT01152359
- Acronym / sponsor ID
- DietChoice / IIR 09-381
- Conditions
- Obesity
- Keywords
- obesity, diet, low carbohydrate, diet, fat-restricted, food preferences, quality of life, patient compliance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- May 2011
- Primary completion
- May 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 29 Jun 2010 (estimated)
- Results
- Posted 22 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obesity is increasingly common and can lead to decreased quality of life, increased medical and psychiatric illness, high health care costs, and early mortality. The problem of obesity is as great in veterans as it is in the general public. Adherence to dietary therapy for obesity is often inadequate, possibly because patients' food preferences are not considered during dietary counseling. Allowing patients to choose a diet based on their food preferences may increase their motivation to adhere to diet counseling. This, in turn, could enhance their weight loss success and, ultimately, reduce the many health complications and costs of obesity. The proposed study will examine whether assessing a person's food preferences, and then allowing the person to choose from two commonly prescribed diets, results in greater weight loss success.
Detailed description
The prevalence of obesity (body mass index [BMI] 30 kg/m2) in US adults has skyrocketed over the past 30 years, and is currently as high or higher in veterans as it is in non-veterans. Thus, identifying effective strategies for treating obesity is both a public health and a VA priority. A variety of diet approaches have proven successful in achieving moderate weight loss in many individuals. Yet, most diet interventions fail to achieve meaningful weight loss in more than a few individuals. This failure likely results from inadequate adherence to the diet.
It is widely felt, but not empirically shown, that targeting the diet to an individual's food preferences will enhance adherence, thereby improving weight loss outcomes. This study will test the commonly proposed assumption that helping patients choose a diet based on their dietary preferences will increase weight loss success relative to assigning or recommending one diet.
The proposed study is a 2-arm randomized controlled trial involving 216 outpatients from Durham VA Medical Center. Participants must be obese (BMI 30 kg/m) VAMC outpatients without unstable health issues. Participants in the experimental arm (Choice) will select from two of the most widely studied diets for weight loss, either a low-carbohydrate, calorie-unrestricted diet (LCD) or a low-fat, reduced-calorie diet (LFD). This choice will be informed by results from a validated food preference questionnaire and a discussion of available diet options with trained personnel. As may occur in the clinical setting, the Choice participants will also have the opportunity to switch to the other diet after 3 months if unsuccessful or dissatisfied with their primary selection. The Choice intervention is designed to enhance the three psychological needs of a person according to self-determination theory (SDT): competence, relatedness, and, in particular, autonomy. This should maximize intrinsic motivation, thereby improving adherence to diet recommendations and increasing weight loss. Participants in the Control arm will be randomly assigned to follow one of the two diets for the duration of follow-up.
All participants will receive diet-appropriate counseling in small group meetings every 2 weeks for 24 weeks, then monthly for another 24 weeks. All participants will also receive brief telephone counseling involving individual goal setting and problem solving halfway through each month in the latter 24 weeks. The primary outcome is weight change from baseline to 48 weeks. Secondary outcomes include adherence to diet by food frequency questionnaire and obesity-specific health-related quality of life. Exploratory analyses will examine whether the impact of choice versus lack of choice on weight loss is moderated by individual differences in the SDT constructs of autonomy orientation, competence, and relatedness.
If assisting patients to choose their diet enhances adherence and increases weight loss, the results will support the provision of diet options to veterans and non-veterans alike, and bring us one step closer to remediating the obesity epidemic faced by the VA and other healthcare systems.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Behavioral: ChoiceParticipants are allowed to choose between a low-carbohydrate or a low-fat diet for weight loss after receiving information about these diets and their food preferences (Choice arm). Then they receive counseling on their chosen diet in a small group format. The low-carbohydrate diet limits carbohydrate intake to 20-40 grams/day initially. The low-fat diet restricts saturated fat to below 30% of daily calories and has a 500-1000 calorie deficit. Group sessions are every 2 weeks for 24 weeks then alternate with telephone calls every 2 weeks for 24 weeks. Phone calls focus on goal setting to maximize weight loss. Participants also receive counseling on behavioral techniques and physical activity. Participants in this arm have the option to switch diets at 12 weeks. |
| Arm 2 | Active comparator | Behavioral: ControlParticipants are randomly assigned to (rather than getting to choose, as in the experimental arm) a low-carbohydrate or a low-fat diet for weight loss (Control arm). Then they receive counseling on their chosen diet in a small group format. The low-carbohydrate diet limits carbohydrate intake to 20-40 grams/day initially. The low-fat diet restricts saturated fat to below 30% of daily calories and has a 500-1000 calorie deficit. Group sessions are every 2 weeks for 24 weeks then alternate with telephone calls every 2 weeks for 24 weeks. Phone calls focus on goal setting to maximize weight loss. Participants also receive counseling on behavioral techniques and physical activity. Participants in this arm do not have the option to switch diets at 12 weeks. |
Who may qualify
- Ages
- Up to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Body mass index 30 or greater
- Stable health
- Desire to lose weight
- Agrees to attend regular visits
- Access to telephone and reliable transportation
Key exclusion criteria (8 listed)
- Certain chronic or unstable disease (kidney or liver disease, type 1 diabetes, hemoglobin A1c 12% or more, insulin use, unstable heart disease, transplant recipient, blood pressure 160/100 or greater, fasting blood triglycerides 600 or greater, LDL cholesterol 190 or greater)
- Pregnancy, breastfeeding, lack of birth control
- Active dementia, psychiatric illness, or substance abuse (past year)
- Weight loss therapy in previous month
- Pacemaker or defibrillator
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 |
|---|---|---|
| ChoiceParticipants are allowed to choose between a low-carbohydrate or a low-fat diet for weight loss after receiving information about these diets and their food preferences (Choice arm). Then they receive counseling on their chosen diet in a small group format. The low-carbohydrate diet limits carbohydrate intake to 20-40 grams/day initially. The low-fat diet restricts saturated fat to below 30% of daily calories and has a 500-1000 calorie deficit. Group sessions are every 2 weeks for 24 weeks then alternate with telephone calls every 2 weeks for 24 weeks. Phone calls focus on goal setting to maximize weight loss. Participants also receive counseling on behavioral techniques and physical activity. Participants in this arm have the option to switch diets at 12 weeks. | Behavioural | Arm 1 |
| ControlParticipants are randomly assigned to (rather than getting to choose, as in the experimental arm) a low-carbohydrate or a low-fat diet for weight loss (Control arm). Then they receive counseling on their chosen diet in a small group format. The low-carbohydrate diet limits carbohydrate intake to 20-40 grams/day initially. The low-fat diet restricts saturated fat to below 30% of daily calories and has a 500-1000 calorie deficit. Group sessions are every 2 weeks for 24 weeks then alternate with telephone calls every 2 weeks for 24 weeks. Phone calls focus on goal setting to maximize weight loss. Participants also receive counseling on behavioral techniques and physical activity. Participants in this arm do not have the option to switch diets at 12 weeks. | Behavioural | Arm 2 |
Primary outcome
Percent Change in Body Weight From Baseline to 48 Weeks
Time frame: Baseline, 48 weeks
2 secondary outcomes
Diet Adherence as Measured by Block Food-frequency Questionnaire (Absolute Percentage Deviation From the Goal Macronutrient Intake--<30% Fat for Low-fat Diet or <10% Carbohydrate for Low-carbohydrate Diet)
Time frame: 48 weeks
Change in Obesity-specific Health-related Quality of Life as Measured by Impact Of Weight On Quality Of Life-Lite (IWQOL-Lite) Questionnaire From Baseline to 48 Weeks
Time frame: Baseline, 48 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24745636McVay MA, Yancy WS Jr, Vijan S, Van Scoyoc L, Neelon B, Voils CI, Maciejewski ML. Obesity-related health status changes and weight-loss treatment utilization. Am J Prev Med. 2014 May;46(5):465-72. doi: 10.1016/j.amepre.2013.11.018.
- BackgroundYancy WS. Peer Support Significantly Improves Compliance in Veterans with Diabetes. U. S. Medicine. 2012 Nov 20.
- Results publication: PubMed 24368474Yancy WS Jr, McVay MA, Brinkworth GD. Adherence to diets for weight loss. JAMA. 2013 Dec 25;310(24):2676. doi: 10.1001/jama.2013.282639. No abstract available.
- Results publication: PubMed 24251378McVay MA, Jeffreys AS, King HA, Olsen MK, Voils CI, Yancy WS Jr. The relationship between pretreatment dietary composition and weight loss during a randomised trial of different diet approaches. J Hum Nutr Diet. 2015 Feb;28 Suppl 2:16-23. doi: 10.1111/jhn.12188. Epub 2013 Nov 20.
- Results publication: PubMed 25149197McVay MA, Voils CI, Coffman CJ, Geiselman PJ, Kolotkin RL, Mayer SB, Smith VA, Gaillard L, Turner MJ, Yancy WS Jr. Factors associated with choice of a low-fat or low-carbohydrate diet during a behavioral weight loss intervention. Appetite. 2014 Dec;83:117-124. doi: 10.1016/j.appet.2014.08.023. Epub 2014 Aug 19.
- Results publication: PubMed 23506974Yancy WS Jr, Coffman CJ, Geiselman PJ, Kolotkin RL, Almirall D, Oddone EZ, Mayer SB, Gaillard LA, Turner M, Smith VA, Voils CI. Considering patient diet preference to optimize weight loss: design considerations of a randomized trial investigating the impact of choice. Contemp Clin Trials. 2013 May;35(1):106-16. doi: 10.1016/j.cct.2013.03.002. Epub 2013 Mar 16.
- Results publication: PubMed 26075751Yancy WS Jr, Mayer SB, Coffman CJ, Smith VA, Kolotkin RL, Geiselman PJ, McVay MA, Oddone EZ, Voils CI. Effect of Allowing Choice of Diet on Weight Loss: A Randomized Trial. Ann Intern Med. 2015 Jun 16;162(12):805-14. doi: 10.7326/M14-2358.
- Results publication: PubMed 26571246Yancy WS Jr, McVay MA, Voils CI. Effect of allowing choice of diet on weight loss--in response. Ann Intern Med. 2015 Nov 17;163(10):805-6. doi: 10.7326/L15-5159. No abstract available.
- Results publication: PubMed 27133551McVay MA, Voils CI, Geiselman PJ, Smith VA, Coffman CJ, Mayer S, Yancy WS Jr. Food preferences and weight change during low-fat and low-carbohydrate diets. Appetite. 2016 Aug 1;103:336-343. doi: 10.1016/j.appet.2016.04.035. Epub 2016 Apr 29.
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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.
William S. Yancy, MD MHS principal investigator
Durham VA Medical Center, Durham, NC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Choice in people with Obesity, run by VA Office of Research and Development 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 6 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 12 Apr 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 22 Oct 2014). 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?
Percent Change in Body Weight From Baseline to 48 Weeks (time frame: Baseline, 48 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 NCT01152359, which also lists 9 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 12 Apr 2019.