The Biobehavioral Impact of Diet Quality on Affect and Craving

NCT04105712 | Completed

• 1 other identifier: HUM00156725
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

The current study experimentally investigates whether reducing highly processed (HP) foods (defined in this study as foods high in added sugars) leads to, psychological and / or behavioral indicators of withdrawal. The following hypotheses are tested:

1. 1.To test the hypothesis that reducing highly processed food intake will result in higher daily reports of physical (e.g. headaches), cognitive (e.g. difficulty concentrating), and affective (e.g., irritability) withdrawal symptoms).
2. 2.To test the hypothesis that reducing highly processed food intake will result in increased negative affect (e.g., irritability, depression) as indicated by and psychological (self - reported distress ratings; daily emotion / mood reports) measures.
3. 3.To test the hypothesis that reducing highly processed food intake will result in increased food craving as indicated by psychological (self - report craving ratings; daily craving report) measures.

Conditions

Food Addiction; Withdrawal

Keywords

withdrawal; highly processed food; food addiction

Outcome Measures

Primary Outcomes (7)

• Increase in affective withdrawal symptoms during post-dietary change assessment using the Highly Processed Food Withdrawal Scale (PRoWS).

  The PRoWS is a validated self-report measure of indicators of withdrawal. Affective withdrawal symptoms are measured by asking participants to complete the Highly Processed Food Withdrawal Scale (PRoWS), which is a validated self-report measure of withdrawal. PRoWS questions ask about current feelings / emotions. Response options are "strongly disagree" "disagree" "feel neutral" "agree" and "strongly agree". Participants are asked to complete these measures every day of the pre and post dietary change. Change in self - report responses on the PRoWS at pre dietary change compared to post dietary change will be used for analyses.

  Through study completion, an average of 1 month

• Increase in negative affect during post-dietary change assessment using ecological momentary assessments (EMA).

  Negative Affect is measured by asking participants to self-report affect (e.g., irritability, depression) on their smart phones throughout the day during pre and post dietary change. Participants are asked to give ratings of their current feelings / emotions and to provide contextual information (location, environment, etc.). Response options are a 5 points scale with extreme ends of scale marked as "strongly disagree" and "strongly agree". Changes in ratings from pre dietary change to post dietary change within subjects will be used for analyses

  Through study completion, an average of 1 month

• Increase in negative affect during post-dietary change assessment using Profile of Mood Scale (POMS).

  Profile of Moods Scale - Abbreviated (POMS) is a well validated, self - report scale of affect. The POMS is used to measure daily global affect. The POMS asks about current feelings / emotions. Response options are "not at all" "a little" "moderate" "quite a bit" and "extremely." Participants are asked to complete these measures daily during pre and post dietary change. Change in self-report responses on the POMS at pre dietary change compared to post dietary change will be used for analyses.

  Through study completion, an average of 1 month

• Increase in stress reactivity during post-dietary change using the Positive and Negative Affect Scale (PANAS) as an indicator of negative affect during a stress - exposure task.

  Participants will complete a stress task during pre and post dietary change. Food cue reactivity symptoms are measured by asking participants to complete the Positive and Negative Affect Scale (PANAS) which asked about current feeling / emotions. Response options are "very slightly / not at all" "a little" "moderately" "quite a bit" or "extremely." Participants are asked to complete these measures before and after completing a stress exposure task during the pre and post dietary change. The magnitude of change in self - report responses in negative affect in response to the stress task on the PANAS at pre dietary change compared to post dietary change will be used for analyses.

  Through study completion, an average of 1 month

• Increased propensity to experience food craving using ecological momentary assessment (EMA).

  Food cravings are measured by asking participants to self-report food cravings and to provide contextual information (location, environment, etc.) on their smart phones throughout the day. Response options are a 5 points scale with extreme ends of scale marked as "strongly disagree" and "strongly agree". The magnitude of change in cravings ratings from pre dietary change to post dietary change within subjects will be used for analyses.

  Through study completion, an average of 1 month

• Increased propensity to experience food craving using the Food Craving Questionnaire (FCQ - S).

  Food cravings are measured by asking participants to complete the Food Craving Questionnaire (FCQ-S) which is a validated measure of current food cravings. Response options are "Strongly Disagree" "Disagree" "Neutral" "Agree" or "Strongly Agree." Participants are asked to complete these measures daily during the pre and post dietary change. Change in self - report responses on the daily report FCQ-S at pre dietary change compared to post dietary change will be used for analyses.

  Through study completion, an average of 1 month

• Increased propensity to experience food craving in response to a cue reactivity task using the Food Craving Questionnaire (FCQ - S).

  Participants will be shown commercial advertisement videos for highly processed foods during the pre and post dietary change. Food cravings are measured by asking participants to complete the Food Craving Questionnaire (FCQ-S) which is a validated measure of current food cravings. Response options are "Strongly Disagree" "Disagree" "Neutral" "Agree" or "Strongly Agree." The magnitude of change is self - report craving on this measure during pre-dietary change compared to post dietary change will be used for analyses.

  Through study completion, an average of 1 month

Secondary Outcomes (4)

• Increased hunger in response to cue - reactivity task using subjective hunger measure.

  Through study completion, an average of 1 month

• Increased craving in response to cue reactivity task using subjective craving measure.

  Through study completion, an average of 1 month

• Increased hunger in response to stress exposure task using subjective measure of hunger.

  Through study completion, an average of 1 month

• Increased craving in response to stress exposure task using subjective measure of craving.

  Through study completion, an average of 1 month

Study Arms (1)

Pre and Post Dietary Change (within subjects)

EXPERIMENTAL

Participants do an initial call for baseline data. Then the active assessment period (pre / post dietary change) begins. Pre - dietary change procedure is 5 days of standard high HP diet while completing daily electronic assessments of withdrawal, ecological momentary assessments, and a phone appointment. Post - dietary change is 5 days of lower HP diet (food provided for 3 of 5 days) while completing daily electronic assessments of withdrawal, ecological momentary assessments, and a phone appointment. Daily assessments of affect, craving, and withdrawal are all virtual. On day 4-5 of post assessment, participants complete a food journal to report foods they ate to ensure compliance to low HP food diet. The pre / post-dietary change phone appointments include 1) psychosocial stress task, 2) cue reactivity task, 3) questionnaires 4) self-reported weight. Participants may also complete a follow up period of questionnaires every other day and self-report weight at the end of follow up.

Behavioral: Dietary Change (low in highly processed foods)

Interventions

Dietary Change (low in highly processed foods) BEHAVIORAL

For post-dietary change, food is provided for 3 days (participants provide own food and do food journals the other 2 days to confirm adherence). University of Michigan's Nutrition Obesity Research Center (NORC)'s Metabolic Kitchen prepares the food. Low HP food diet is based on prior methods where participants are placed on an isocaloric diet composed of 5% or less of calories from added sugar and 10% or less of overall calories from total sugar. No foods that meet the criteria for a HP food (defined by Kant and colleagues) that corresponds to: sweeteners (sugar, candy, etc); carbonated and non-carbonated beverages (fruit drinks, sweetened / diet beverages, etc.); baked / dairy desserts (cookies, ice cream, etc.); salted snacks (potato chips, etc.) and fast foods (pizza, cheeseburgers, etc.) are included in diet portions. The overall macro nutrient composition of the diet will be approximately 20-25% of kcal from protein, 30-35% of kcal from fat, and 40-50% of kcal from carbohydrates.

Pre and Post Dietary Change (within subjects)

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 25 to 40
• Access to internet, private computer and smart phone
• Overweight (self-report BMI above 25.0)
• Moderately or Highly motivated to eat a healthier diet
• Mild, moderate or severe levels of addictive like eating (2 or higher on the Yale Food Addiction Scale)
• Fluent in english
• Willing to follow dietary guidelines provided by study team and eat only provide food for 3 days. Willing to delay dietary change until instructed to do so

You may not qualify if:

• Use of nicotine in the past month, cannabis in the past month, or illicit drugs in the past 6 months
• Weight fluctuation of 20+ pounds in the last 3 months
• Attempted weight loss using a formal weight loss program (e.g. weight watchers) in the last month
• Prior weight loss surgery (e.g. bariatric surgery)
• Medications or medical conditions that may impact study results such as medications that impact appetite, heart rate, or reward functioning (e.g. taking synthroid or has diabetes)
• Current major psychiatric diagnoses (e.g., bipolar, schizophrenia, substance use disorder, eating disorder)
• A diagnosis of a restrictive eating disorder in the past 5 years (anorexia nervosa, bulimia nervosa, purging disorder)
• Significant dietary restrictions (e.g. allergies, veganism)
• currently pregnant, breastfeeding, trying to get pregnant, or within 6 months of giving birth

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Food Addiction

Condition Hierarchy (Ancestors)

Behavior, Addictive; Compulsive Behavior; Impulsive Behavior; Behavior; Feeding and Eating Disorders; Mental Disorders

Study Officials

• Ashley Gearhardt, Ph.D

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychology

Model Details: Multi-method, within subjects, prospective, experimental design

Study Record Dates

• First Submitted: September 23, 2019
• First Posted: September 26, 2019
• Study Start: June 18, 2019
• Primary Completion: October 21, 2021
• Study Completion: October 21, 2021
• Last Updated: November 1, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 5 years following article publication
• Access Criteria: Researchers who provide a methodologically sound proposal will be able to access data to achieve aims outlined in the approved proposal. Proposals should be directed to agearhar@umich.edu to gain access. Data requestors will need to sign a data access agreement. Data will be stored by the research team for 5 years.

Locations

US (1)