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Episodic Future Thinking and Weight-Loss

8 juni 2021 uppdaterad av: Leonard Epstein, State University of New York at Buffalo

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

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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

120

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Missouri
      • Saint Louis, Missouri, Förenta staterna, 63130
        • Washington University in St. Louis

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

10 år till 14 år (Barn)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Episodic Future Thinking Group
The experimental group (N=20 families; N=40 total) will receive the Episodic Future Thinking (EFT) intervention. 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.

Placebo-jämförare: Healthy Thinking Group
The placebo group (N=20 families; N=40 total) will receive the Healthy Thinking (HT) intervention. HT encourages individuals to focus on the nutritional characteristics of food and the healthy benefits of physical activity.

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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
BMI for parents Percent over BMI for children
Tidsram: Change from Baseline BMI/Percent over BMI at week 11, week 19, week 27
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
Weight
Tidsram: Change from Baseline weight at week 11, week 19, week 27
Weight will be measured in lbs
Change from Baseline weight at week 11, week 19, week 27

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Delayed discounting
Tidsram: Change from Baseline DD at week 11, week 19, week 27
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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Denise Wilfley, PhD, Washington University School of Medicine
  • Huvudutredare: Leonard Epstein, PhD, State University of New York at Buffalo

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

31 maj 2019

Primärt slutförande (Faktisk)

20 juni 2020

Avslutad studie (Faktisk)

31 december 2020

Studieregistreringsdatum

Först inskickad

30 oktober 2018

Först inskickad som uppfyllde QC-kriterierna

5 november 2018

Första postat (Faktisk)

6 november 2018

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

11 juni 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

8 juni 2021

Senast verifierad

1 juni 2021

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 201807151
  • R01HD080292 (U.S.S. NIH-anslag/kontrakt)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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