- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03226938
Adhering to Dietary Approaches for Personal Taste (ADAPT)
Adhering to Dietary Approaches for Personal Taste (ADAPT) Study
Study Overview
Status
Conditions
Detailed Description
Public interest in nutrition is at the forefront of wellness and food culture, and the number of followers of various popular diets has grown in the last decade. These popular diets span the spectrum from vegan/vegetarian to low-carb/Paleo. Compared to typical American dietary patterns, which are high in added sugar and fat, these emerging diet patterns may offer improved dietary quality due to a reduction in added sugars and refined carbohydrates. Observational cohort studies have associated improved diet quality and health benefits with various types of plant-based diets, and randomized controlled trials have shown these diets to be beneficial for reducing body weight and cardiometabolic risk. Randomized controlled trials have also demonstrated improvements in cardiometabolic risk factors among individuals following low-carb and Paleo diets. In spite of these documented health benefits, there is limited intervention and longitudinal data on followers of popular diets. Evidence on successful adherence to such diets is further limited and may be of interest.
The Adhering to Dietary Approaches for Personal Taste (ADAPT) Recruitment Feasibility Survey (FS), conducted in the summer of 2015, demonstrated interest on the part of popular diet followers in participating in nutrition research. This planning survey identified over 7,000 individuals expressing interest in being contacted for a future study on dietary patterns, and the ADAPT study exam 1 aims to recruit from this pool of participants. To date, research has identified psychobiological, cultural, social, and environmental factors that enable individuals to adhere to weight loss and other diets over the long-term (2+ years). These adherence factors include habit formation, social support, a supportive environment, self-efficacy including knowledge of nutrition, and motivation. However, no observational study has recruited individuals following a variety of self-identified diets to examine (1) the actual nutrient composition of popular dietary patterns compared to targeted intakes, (2) the association of predictors of adherence identified in weight-loss research to these specific dietary patterns chosen for personal preference, and (3) which of these factors are most prevalent among self-identified long-term followers and how this may differ across diet groups. The question of how individuals can successfully adhere to a variety of healthier dietary patterns is of highest public health importance because of the growing burden of disease risk in the US.
The specific aims of this study are as follows: 1) Compare the mean nutrient composition, diet quality, and degree of adherence among US-based, long-term followers (>2 years) of popular diets to determine how closely individuals met the prescribed targeted nutrient profiles; 2) Compare the self-reported body weight and BMI across diet patterns; 3) Assess the prevalence of predictors of dietary adherence (psychobiological, cultural, social, economic, and environmental) across diet patterns.
Exam 1 (baseline) recruitment will target a variety of populations who choose to eat less common or lesser-studied diets, with a trend towards avoiding processed foods and added sugars, such as: raw vegan, vegan, vegetarian, pescatarian, whole food, Dietary Approaches to Stop Hypertension (DASH), gluten-free, dairy-free, Mediterranean, Paleo, Weston Price, or diets specifically for weight loss. Participants will be recruited from a pool of subjects who expressed interest in future study involvement as a part of the ADAPT FS. In addition, the investigators will continue to recruit additional participants electronically, through a variety of online resources that may include affinity-based email lists, social media (Facebook, Twitter), referrals from family and/or friends in the FS, and personal communications from study investigators.
Exam 1 participants who provide permission to be contacted for future research in the Exam 1 consent will be contacted within 1-5 years after exam 1 participation, with an invite to participate in the first follow-up study (Exam 2). Eligible Exam 2 participants (defined as those following one of 5 dietary patterns of interest) will be additionally contacted to participate in a sub-study assessing different methods of collecting dietary intake data.
Survey Questionnaires Exam 1: The investigators will administer a demographics and lifestyle questionnaire, supplement use questionnaire, and a variety of previously validated questionnaires hosted online in Qualtrics. Questionnaires on demographics, supplement use, diet choice, diet history, socioeconomic status, food access/availability, cost, and convenience have been created in Qualtrics. The following previously validated questionnaires were also created in Qualtrics: the Nutrition Self-Efficacy Scale, Three-Factor Eating Questionnaire, Power of Food Scale, Yale Food Addiction Scale, Social Support and Eating Habits Survey, Self-Report Habit Index,International Physical Activity Questionnaire Long Form, and the Pittsburgh Sleep Index. The investigators will assess dietary intakes using the following: (1) the Diet History Questionnaire II (DHQ II), a web-based food frequency questionnaire from the National Cancer Institute (NCI) and (2) the web-based Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24), also from NCI. The ASA24 will be administered, unannounced, to a subset of participants to try to minimize instances of participants altering their diet, either intentionally or unintentionally, as a result of knowing about an upcoming 24-hour recall questionnaire.
The questionnaires will take approximately 3-4 hours in total to complete but will be staggered over the course of 6-12 weeks to reduce respondent burden. A total of 17 questionnaires will be administered, staggered in batches of 1-3 questionnaires at a time, resulting in participants being contacted a minimum of 10 times over the course of approximately 6-12 weeks. Participants who miss or do not complete questionnaires may be contacted more frequently with reminder emails.
Exam 2: The investigators will administer the following surveys-- Follow-up demographics & lifestyle (25 min), Brief medical history (15 min), SF36 health questionnaire (15 min), WHO quality of life questionnaire (15 min). Participants will receive a weekly email for 4 weeks with each week's questionnaire, and they will be contacted for an additional 4 weeks, if needed, with a request to make-up incomplete questionnaires.
Dietary Intake Study: Eligible exam 2 participants will be invited to complete the following questionnaires as part of a sub-study-- NCI Diet History Questionnaire (30-40 minutes to complete), 3-day food record (3 days, approximately 1hr/day), NCI ASA 24-hr dietary recall (30-45 min). Participants will receive one questionnaire per week for 3 weeks and will then be contacted to make-up missing questionnaires (if applicable) for an additional 6 weeks. The sub-study aims to enroll 250 participants.
Participants will provide electronic consent prior to beginning each survey (Exam 1, Exam 2, and the Dietary Intake Sub-study) by reading a disclosure and answering questions aimed at capturing all elements required by the Tufts University Health Sciences Institutional Review Board (IRB) for consent.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02111
- Tufts University (Jean Mayer USDA Human Nutrition Research Center on Aging)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 18 years of age
- access to internet in order to complete online questionnaires.
Exclusion Criteria: None.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Mean nutrient composition
Time Frame: through study completion, approximately 1 year
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Compare actual intake calculated from participant-reported diet history questionnaires and/or diet recalls to targeted nutrient composition of the respective dietary pattern reported by the participant.
Targeted nutrient composition will be calculated using 7-day meal plans from popular dietary patterns of interest.
These 7-day meal plans will be generated from sources of nutrition information identified by participants in the ADAPT Feasibility Survey which was conducted in the summer of 2015 to demonstrate whether popular diet followers would be interested in participating in nutrition research.
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through study completion, approximately 1 year
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Dietary adherence
Time Frame: through study completion, approximately 1 year
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Adherence will be defined by self-report as follows: adhering to diet > 95% of the time (high adherers), between 75-95% (moderate adherers); < 75% time (lower adherers).
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through study completion, approximately 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diet quality
Time Frame: through study completion, approximately 1 year
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Dietary intake data from diet history questionnaire and/or diet recalls will be used to create a Healthy Eating Index (HEI) score to measure diet quality
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through study completion, approximately 1 year
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Body weight
Time Frame: through study completion, approximately 1 year
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Body weight will be self-reported by participants
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through study completion, approximately 1 year
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Body mass index (BMI)
Time Frame: through study completion, approximately 1 year
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BMI will be calculated based on self-reported height and body weight using the following formula: BMI = (Weight in Pounds / (Height in inches x Height in inches)) x 703
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through study completion, approximately 1 year
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Self-reported quality of life
Time Frame: through study completion, approximately 1 year
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Measured by World Health Organization (WHO) Quality of Life questionnaire; domain scores range from 4-20 (and can be transformed to range 0-100) with higher scores denoting higher quality of life.
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through study completion, approximately 1 year
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 12472 (Stanford IRB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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