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Episodic Future Thinking and Weight-Loss

8 juin 2021 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

120

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Missouri
      • Saint Louis, Missouri, États-Unis, 63130
        • Washington University in St. Louis

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

10 ans à 14 ans (Enfant)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La 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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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].
Comportemental: 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.
Comparateur placebo: 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.
Comportemental: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
BMI for parents Percent over BMI for children
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Delayed discounting
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

State University of New York at Buffalo

Collaborateurs

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Washington University School of Medicine

Les enquêteurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

31 mai 2019

Achèvement primaire (Réel)

20 juin 2020

Achèvement de l'étude (Réel)

31 décembre 2020

Dates d'inscription aux études

Première soumission

30 octobre 2018

Première soumission répondant aux critères de contrôle qualité

5 novembre 2018

Première publication (Réel)

6 novembre 2018

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

11 juin 2021

Dernière mise à jour soumise répondant aux critères de contrôle qualité

8 juin 2021

Dernière vérification

1 juin 2021

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 201807151
  • R01HD080292 (Subvention/contrat des NIH des États-Unis)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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