Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03226938 |
| Other study ID # |
12472 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 24, 2017 |
| Est. completion date |
February 11, 2022 |
Study information
| Verified date |
February 2022 |
| Source |
Tufts University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Understanding the impact of dietary patterns, exercise, and behavior change in the prevention
of disease is paramount to improving the health and well-being of future generations and
economies. A gap in the research is the lack of data on factors that predict successful
behavior change for sustained dietary practices chosen for health or other personal reasons.
To date, no survey exists that was designed to target persons following a wide range of
popular dietary patterns (e.g., Paleo, low-carb, vegetarian, vegan, Mediterranean,
gluten-free, etc.). These dietary patterns, which offer great variation in macronutrient
composition, are unique and unexplored in other similar surveys to date, making their
examination innovative. Adhering to Dietary Approaches for Personal Taste (ADAPT) will be the
first large cohort of its type that is focused on adherence to popular dietary patterns,
providing the opportunity to better understand how individuals can be supported to
successfully maintain a specific dietary practice, and, in the long-term, how these practices
may influence parameters of healthy aging.
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.
