- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03731325
Episodic Future Thinking and Weight-Loss
The Effect of Episodic Future Thinking on Weight-Loss
Family-based treatments (FBT) for obesity have been shown to be effective in achieving significant weight reductionin overweight or obese children and parents [Altman & Wilfley, 2015]. One component of the current FBT programused in this study that has received little attention is thought training, specifically episodic future thinking (EFT). EFTteaches individuals to pre-experience events, or think prospectively, about future events as if they were happeningnow and has been shown to reduce delay discounting (DD) which is defined as discounting smaller rewards now for a larger reward in the [Daniel, Said, Stanton, & Epstein]. Furthermore, EFT has been shown to help people purchase fewer calories when they are grocery shopping [Hollis-Hansen et al., 2019], thereby displaying potential to be an effective measure in modulating the food environment in homes and may play a role in changing eating behaviors related to weight loss [Appelhaus et al.,2019].
Given the power of EFT in promoting the purchase of fewer calories, it is plausible that EFT training focused around grocery shopping during FBT could help shift one's thought processes towards healthier food choices, promoting behavioral change that has lasting impact on the home environment. Thus, the primary purpose of this study is to assess whether EFT training promotes active behavioral change pertaining to grocery shopping during FBT. In turn,this resulting behavior change could lead to healthier eating behavior and may promote weight loss for the whole family.
We hypothesize:
- There will be a reduction in BMI for adults/percent over BMI for children and weight from baseline
- There will be a reduction in delay discounting for children
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study program is organized into 15 sessions. There is a mix of group sessions, individual family in-person sessions, and individual family phone sessions. Each session is outlined below:
WEEK 0 - Baseline Session: In-Lab Group Session - All Baseline sessions were completed as planned in lab.
First, upon arriving to the lab, each dyad will be escorted to a private room and will complete the following:
- Have height and weight measured.
- Complete surveys: Consideration of Future Consequences Scale (CFCS), EDE-Q (Parent), KEDS (Child)
- Complete the Delay Discounting Task, the Online Grocery Shopping Task, and Home Food Inventory. A letter was sent to each family explaining the change from in-home visits with the Cupboard inventory to the self-completed Home Food Inventory, due to growing concern over COVID-19.
- Receive first assessment payment ($40 dollars)
Following steps 1-4, the families will take part in a group session to learn the core components of the program in presentations by the research staff.
Weeks 1-14 ~ 1 hour; Weekly In-Lab Group Sessions - Due to the COVID 19 outbreak, in-person assessments and interventions are no longer feasible. Therefore, the researchers will carry out these study components remotely. The programs that will be used are phone, Zoom, and Qualtrics.
- The day of their assigned parent group session, each family will email the study coordinator a photocopy of their food receipts, receipt forms, and food log. They will self-report weights via email as well.
Children will join a child-only Zoom group video session, and parents will join a parent-only Zoom video session. Each group will be led by a study team member. In these sessions, participants will do the thought training program, and talk to staff and other group members about progress in the program. Each parent-child dyad will meet via Zoom or phone at a separate time with a study team member to complete the case management portion of the program.
- During the 15-week intervention, participants will be asked to log their activity related to the program in food logs.
- Researchers will access the information and send feedback to the participants (via text, phone, and/or email) to help them succeed in the program.
Throughout the baseline period, the study team will assess all participants' adherence levels through looking at data from the food logs and the collected receipts.
Once a family has been determined to be adhering to the study protocol, the participant will then be randomly assigned to either the 7- week or 10-week baseline group. After the assigned baseline, participants will be eligible to start the EFT intervention.
An assessment session will take place the week the group starts the intervention, which will consist of 1- Self-reported weights via email 2- Complete surveys: EDE-Q (Parent), KEDS (Child) on Qualtrics 3- Complete EFT cue generation needed for thought training 4- Complete the Delay Discounting Task on Qualtrics and the Virtual Shopping Task via emailed instructions.
5- Review weekly receipts 6- Receive assessment session payment 7. Receive a EFT Cue Retrieval technology tutorial via emailed instructions, or a Zoom or phone session as requested
EFT Cue Retrieval: The experimenter will then train participants in both groups on how to retrieve cues from their cell phone or alternative WiFi device, to pay attention to and think about the cues, and how to adhere to the study's expectations for utilizing to the cues. Participants will be told to use their cues any time they need to, especially around eating episodes, using the prompt response website - Mobile Audio Management and Response Tracker (MAMRT)(Sze, Daniel, Kilanowski, Collins, Epstein, 2015).
Assessment measures must be completed the day of their assigned group sessions. Child and Parent Zoom-based group sessions will be conducted at their scheduled times, as well as scheduled case management.
Week 15 ~ Final Assessment - All assessment measures for week 15 will be conducted remotely, unless COVID-19related restrictions are lifted, in which an in-lab visit for final measurements may be conducted.
- Self-reported heights and weights
- Complete surveys on Qualtrics: Consideration of Future Consequences Scale (CFCS), EDE-Q (Parent), KEDS (Child),Formative Questionnaire, TT Frequency of Use
- Complete the Delay Discounting Task, Shelf Life Inventory, and Home Food Inventory on Qualtrics, and the Virtual Shopping Task via emailed instructions.
- Review weekly receipts and receive payment if applicable ($25 dollars) via check request, Amazon Pay or Forte.
- Receive final assessment session payment ($45 dollars) via check request, Amazon Pay or Forte.
Assessment measures must be completed the day of their assigned group sessions. Child and Parent Zoom-based group sessions will be conducted at their scheduled times, as well as scheduled case management.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Missouri
-
Saint Louis, Missouri, United States, 63130
- Washington University in St. Louis
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion:
- Child age between 10-14
- Child height and weight that calculates to a BMI above the 85th percentile (BMI in overweight/obesity range)
- Parent height and weight that calculates to a BMI above 18
- Possession of at least one electronic device (per family) with WiFi capabilities (e.g. smartphone, tablet, computer)
- Home internet access
- Motivation to lose weight
Exclusion:
- Disordered eating patterns (e.g. binge-eating disorder, extreme weight-loss behaviors)
- A family history of eating disorders (siblings, children, parents, or grandparents)
- Medical conditions that are known to interfere with weight-loss (e.g. type 1 diabetes, thyroid disease)
- Medical conditions that may affect their ability to use the computer for a prolonged period of time or follow study protocol
- Psychopathology or disabilities that would limit adherence to protocol (e.g. depression, suicidality, ADHD). Participant will only be excluded if the disability would not allow them to adhere to protocol. Just having the disability does not exclude them. Suicidality would be automatically be exclusionary)
- Substance use, abuse, or dependence (e.g. binge drinkers, illicit substance users, alcoholics)
- Plans to start or stop a medication that may affect appetite/weight-loss during the intervention period
- Have started a medication within 6 months that is affecting appetite/weight-loss
- Plans to move out of the area during the treatment period
- Pregnancy/breastfeeding or plans of becoming pregnant during the study period
- Is participating in another weight-loss program
- Can not successfully record eating behavior in the MyFitnessPal app
- A) Had bariatric surgery less than one year ago B) If the potential participant had bariatric surgery over a year ago, their weight has not been stable for at least 6 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Episodic Future Thinking Group 7-week baseline
The experimental group will receive the Episodic Future Thinking (EFT) intervention after a 7-week baseline.
EFT teaches individuals to pre-experience events, or think prospectively, about future events as if they were happening now [Atance].
|
Participants in the Episodic Future Thinking (EFT) Group will train with EFT throughout the entire study. As part of the training, research staff will help participants create "cues." Cues are descriptions of future events the participant can vividly imagine as happening right now. Participants will be instructed to think about the EFT cues they created to help them focus on the future and importance of reaching their weight-loss goals. Participants will be instructed to use their EFT cues at least once per day, but will be encouraged to use their cues with every eating and physical activity decision. |
|
Experimental: Episodic Future Thinking Group 10-week baseline
The experimental group will receive the Episodic Future Thinking (EFT) intervention after a 10-week baseline.
EFT teaches individuals to pre-experience events, or think prospectively, about future events as if they were happening now [Atance].
|
Participants in the Episodic Future Thinking (EFT) Group will train with EFT throughout the entire study. As part of the training, research staff will help participants create "cues." Cues are descriptions of future events the participant can vividly imagine as happening right now. Participants will be instructed to think about the EFT cues they created to help them focus on the future and importance of reaching their weight-loss goals. Participants will be instructed to use their EFT cues at least once per day, but will be encouraged to use their cues with every eating and physical activity decision. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in BMI for Parent Participants From Baseline at Weeks 8, 11 and 15
Time Frame: Change from Baseline BMI at week 8, 11 and 15
|
Height (cm) and weight (lbs) will be assessed to calculate BMI (kg/m^2) for parents.
Change will be assessed at baseline, week 8, 11 and 15 from baseline.
|
Change from Baseline BMI at week 8, 11 and 15
|
|
Change in Weight for Parents From Baseline at Weeks 8, 11 and 15
Time Frame: Change from Baseline weight at week 8, 11 and 15
|
Weight was measured in lbs
|
Change from Baseline weight at week 8, 11 and 15
|
|
Change in BMI Percentile for Children
Time Frame: Baseline, 8, 11 and 15 weeks
|
Change in BMI percentile for children from 0, 8, 11 and 15 weeks
|
Baseline, 8, 11 and 15 weeks
|
|
Change in Weight for Children From Baseline at Weeks 8, 11 and 15
Time Frame: Change from Baseline weight at week 8, 11 and 15
|
Weight was measured in lbs and examined as change from baseline in lbs at week 8, 11 and 15
|
Change from Baseline weight at week 8, 11 and 15
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Delay Discounting for Children
Time Frame: Baseline, 10 weeks, 15 weeks
|
Delay Discounting will be measured using monetary Delay Discounting tasks with $100 as the delayed reward.
Delay discounting is assessed using Area Under the Curve (AUC), or time*indifference point/delay.
AUC for delay discounting included time (x-axis) and indifference point (y-axis), or the amount of money at which the immediate and delayed options are approximately equal.
Indifference points are a proportion of the max amount (range 0 - 100) and delays are calculated as proportion of max delay.
AUC adds the calculated areas for each timepoint from the previous timepoint.
AUC ranges from 0 (most impulsive, did not choose delay) to 100 (least impulsive, always chose delay).
As this is a measure that is standardized, units are proportion of maximum delayed reward x proportion of maximum delay.
|
Baseline, 10 weeks, 15 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Denise Wilfley, PhD, Washington University School of Medicine
- Principal Investigator: Leonard Epstein, PhD, State University of New York at Buffalo
Publications and helpful links
General Publications
- John LK, Loewenstein G, Troxel AB, Norton L, Fassbender JE, Volpp KG. Financial incentives for extended weight loss: a randomized, controlled trial. J Gen Intern Med. 2011 Jun;26(6):621-6. doi: 10.1007/s11606-010-1628-y. Epub 2011 Jan 20.
- Daniel TO, Stanton CM, Epstein LH. The future is now: comparing the effect of episodic future thinking on impulsivity in lean and obese individuals. Appetite. 2013 Dec;71:120-5. doi: 10.1016/j.appet.2013.07.010. Epub 2013 Jul 31.
- Benoit RG, Gilbert SJ, Burgess PW. A neural mechanism mediating the impact of episodic prospection on farsighted decisions. J Neurosci. 2011 May 4;31(18):6771-9. doi: 10.1523/JNEUROSCI.6559-10.2011.
- Boyer P. Evolutionary economics of mental time travel? Trends Cogn Sci. 2008 Jun;12(6):219-24. doi: 10.1016/j.tics.2008.03.003. Epub 2008 May 28.
- Daniel TO, Said M, Stanton CM, Epstein LH. Episodic future thinking reduces delay discounting and energy intake in children. Eat Behav. 2015 Aug;18:20-4. doi: 10.1016/j.eatbeh.2015.03.006. Epub 2015 Mar 28.
- Atance CM, O'Neill DK. Episodic future thinking. Trends Cogn Sci. 2001 Dec 1;5(12):533-539. doi: 10.1016/s1364-6613(00)01804-0.
- Leahey TM, Fava JL, Seiden A, Fernandes D, Doyle C, Kent K, La Rue M, Mitchell M, Wing RR. A randomized controlled trial testing an Internet delivered cost-benefit approach to weight loss maintenance. Prev Med. 2016 Nov;92:51-57. doi: 10.1016/j.ypmed.2016.04.013. Epub 2016 Apr 17.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201807151
- R01HD080292 (U.S. NIH Grant/Contract)
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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