Episodic Future Thinking and Weight-Loss

Overweight and Obesity Clinical Trial

Official title:

The Effect of a Monetary Incentive Program and Episodic Future Thinking on Weight-Loss

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03731325
• Other study ID #: 201807151
• Secondary ID: R01HD080292
• Status: Completed
• Phase: N/A
• Start date: May 31, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: June 2021
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Monetary incentive programs can reduce weight short-term; however, many studies have shown weight regain when the incentive program ends. This relapse is unsurprising; it is well-established that a specific behavior is extinguished when reinforcement for the behavior is removed. It is unlikely, then, given the expense, that monetary incentive programs could be implemented long-term for chronic diseases like obesity. Thus, programs are needed to bridge the gap between the short-term effects of a monetary incentive program and long-term effects at program end.

A program that could be effective at bridging this gap is thought training, namely, episodic future thinking (EFT). EFT teaches individuals to think prospectively about future events as if they are happening now. EFT can reduce delay discounting (DD) which is defined as discounting larger rewards in the future for smaller rewards now (e.g. people with high DD levels may place more value on eating an unhealthy food now vs. the future health benefits of forgoing the food). It is suggested that EFT increases the value of the future reward and helps individuals make choices with lasting benefits.

Given the power of EFT to reduce DD, it is plausible that EFT training during an incentive program could help shift one's thought processes towards the long-term consequences of behavior, promoting behavioral change even after the incentive program ends. Thus, the purpose of this study is to assess whether EFT promotes weight-loss in N=40 parent/child dyads (BMI ≥ 25) after a monetary incentive program ends vs. a control thought training program, Healthy Thinking (HT).

We hypothesize:

• The EFT and HT group will both have a reduction in BMI for adults/percent over BMI for children and weight from baseline during the monetary incentives program.

• The EFT vs. HT group will have a greater reduction in BMI/percent over BMI and weight from baseline during the monetary incentives program.

• The EFT group will maintain the reduction in BMI/percent over BMI and weight from baseline after the termination of the monetary incentives program.

• The HT group will not maintain the reduction in BMI/percent over BMI and weight from baseline after the termination of the monetary incentives program.

• The EFT vs. HT group will have a reduction in DD over time.

Description:

The study program is organized into 20 sessions. There is a mix of group sessions, individual family in-person sessions, and individual family phone sessions. Each session is outlined below:

Session 1 will be an in-lab screening session to ensure participants are eligible to participate. During this session, participants will have their height and weight measured and complete surveys: Eating Disorders Examination Questionnaire (EDE) for parents, Kid's Eating Disorders Survey (KEDS) for kids, Sociodemographic, and a clinical interview. Participants will also be instructed to track their eating and physical activity in MyFitnessPal.

Session 2 will be a group workshop. Families will learn the core components of the program in presentations by the research staff. The workshop will also include activities to keep the families engaged and a meal will be provided. If the participants attend the workshop, successfully logged in MyFitnessPal, and still want to participate, they will be randomized to a treatment group and scheduled for a baseline session.

Session 3 will be a baseline session. Participants will have their height, weight, and delayed discounting (DD) measured to establish baseline data. Participants will also complete baseline surveys including: Consideration of Future Consequences Scale (CFCS), Palatable Eating Motives Scale (PEMS), Relative Reinforcing Value, and Living to 75 assessment. Participants will also create their first EFT or HT cues.

For EFT cue generation, participants will talk about a specific future positive event where they imagine themselves in vivid detail. To generate the cues, participants in the EFT group will be given standardized instructions asking them to think about and list specific events that they are looking forward to in the future (ex: parties, holidays). Participants will be instructed to generate the EFT cue by describing their events, including a detailed description of themselves at the specific event. After the participant has created their cues, they will save their cue for later use in the intervention.

To control for the timing and attention of the EFT cue, participants in the HT group will generate cues that include specific nutrition statements that they feel will be of personal benefit. To generate the cues, participants in the HT group will select from a list of nutrition statements that they feel will be personally useful in making healthy decisions.After the participant has created their cues, the participant will save their cue for later use in the intervention.

Sessions 4-19 will be intervention sessions split into 2 phases:

Phase 1:

Sessions 4-11 will be in person sessions between an individual family and a researcher. Participants will have weight measured, do the thought training program, and talk to staff about progress in the program. Phase 1 is when the monetary incentives program will be implemented.

Phase 2:

Sessions 12-19 will be phone sessions between an individual family and a researcher. Participants will do the thought training program and talk to staff about progress in the program.

During both phases of intervention, participants will be encouraged to send weekly weights from a provided Bluetooth enabled scale. Participants will also be asked to log their activity related to the program in the MyFitnessPal app. Researchers will access the information and send feedback to the participants (via text, phone, and/or email) to help them succeed in the program.

Session 20 will be an in person session between an individual family and the researcher. This session will act as a follow-up session as there will be an 8 week gap between Session 19 and Session 20 where there is no study intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 31, 2020
• Est. primary completion date: June 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity
• Weight Loss

Intervention

Behavioral:
• Episodic Future Thinking Group
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.
• Healthy Thinking Group
Participants in the Healthy (HT) Group will train with HT throughout the entire study. As part of the training, research staff will help participants create "cues." Cues are statements about the nutrition of food and the health benefits of physical activity. Participants will be instructed to think about the HT 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 HT cues at least once per day, but will be encouraged to use their cues with every eating and physical activity decision.

Locations

Country	Name	City	State
United States	Washington University in St. Louis	Saint Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
State University of New York at Buffalo	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (7)

Atance CM, O'Neill DK. Episodic future thinking. Trends Cogn Sci. 2001 Dec 1;5(12):533-539. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI for parents Percent over BMI for children	Height (cm) and weight (lbs) will be assessed to calculate BMI and percent over BMI	Change from Baseline BMI/Percent over BMI at week 11, week 19, week 27
Primary	Weight	Weight will be measured in lbs	Change from Baseline weight at week 11, week 19, week 27
Secondary	Delayed discounting	Delayed discounting (DD) will be measured with a standard electronic DD task where participants will be asked to make choices between smaller amounts of money now vs. larger amounts of money in the future.	Change from Baseline DD at week 11, week 19, week 27