Clinical trial NCT03731325: Episodic Future Thinking and Weight-Loss
Official title: The Effect of Episodic Future Thinking on Weight-Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Keywords: Episodic future thinking
Obesity
Family based treatment
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Washington University School of Medicine
First posted: 2018-11-06
Enrollment: 7
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-concurrent multiple baseline design;participants will be randomized to a 7 week, or 10 week group with staggered baseline periods followed by 4-8 weeks of the intervention consisting of FBT and EFT. Enrollment is for parent-child dyads.
Primary purpose: TREATMENT

Brief summary: 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

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:

1. Have height and weight measured.
2. Complete surveys: Consideration of Future Consequences Scale (CFCS), EDE-Q (Parent), KEDS (Child)
3. 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.
4. 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.

1. 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.
2. 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.

   1. During the 15-week intervention, participants will be asked to log their activity related to the program in food logs.
   2. 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.

1. Self-reported heights and weights
2. Complete surveys on Qualtrics: Consideration of Future Consequences Scale (CFCS), EDE-Q (Parent), KEDS (Child),Formative Questionnaire, TT Frequency of Use
3. Complete the Delay Discounting Task, Shelf Life Inventory, and Home Food Inventory on Qualtrics, and the Virtual Shopping Task via emailed instructions.
4. Review weekly receipts and receive payment if applicable ($25 dollars) via check request, Amazon Pay or Forte.
5. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in BMI for Parent Participants From Baseline at Weeks 8, 11 and 15
timeFrame: Change from Baseline BMI at week 8, 11 and 15
measure: Change in Weight for Parents From Baseline at Weeks 8, 11 and 15
timeFrame: Change from Baseline weight at week 8, 11 and 15
measure: Change in BMI Percentile for Children
timeFrame: Baseline, 8, 11 and 15 weeks
measure: Change in Weight for Children From Baseline at Weeks 8, 11 and 15
timeFrame: Change from Baseline weight at week 8, 11 and 15
Secondary outcomes:
measure: Delay Discounting for Children
timeFrame: Baseline, 10 weeks, 15 weeks
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
Study officials:
affiliation: State University of New York at Buffalo
name: Leonard Epstein, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Denise Wilfley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.