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Bewertung des Einflusses der Wahrnehmung von Unvorhersehbarkeit auf objektive Messungen des Lebensmittelkonsums und des Stoffwechsels

2. November 2026 aktualisiert von: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Bewertung des Einflusses der Wahrnehmung von Unvorhersehbarkeit auf objektive Maße des Lebensmittelkonsums und des Stoffwechsels: Eine naturkundliche Studie

Background:

Many people in the United States are overweight or obese. This natural history study will look into how life events during childhood can impact eating behaviors and weight gain as adults.

Objective:

To explore how childhood experiences affect adult eating behaviors.

Eligibility:

Healthy people aged 18 to 60 years.

Design:

Participants will have 3 clinic visits.

They will be screened with blood tests. They will answer questions about their alcohol and tobacco use.

At the next visit, participants will undergo these activities:

Parts of their body (such as waist, neck, and thighs) will be measured with a tape.

They will have an imaging scan to find out how much body fat they have.

They will start wearing a device like a wristwatch that measures their physical activity. They will wear this device for up to 10 days.

They will wear a device on their upper arm or belly that measures blood glucose (sugar) levels. Participants will wear this for 7-10 days.

They will answer questions about their education, childhood, and routines.

They will receive a kit to collect a stool sample at home.

At the last visit, participants will have these tests:

Participants will relax and breathe normally while wearing a clear, plastic canopy that fits over their entire head.

Blood samples will be taken before and after participants drink a sugary drink.

Participants will be offered a large selection of foods for lunch. They will eat as much as they want. Then they will answer questions about how they feel about food and themselves.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Detaillierte Beschreibung

Study Description:

The unpredictability schema - "a pervasive belief that other people cannot be trusted and future outcomes cannot be predicted or controlled" - has been hypothesized to (1) be shaped by parental/household dynamics and (2) impact appetitive and consumptive behaviors. However, studies on appetitive behaviors were mostly based on self-report and to our knowledge, no studies have examined objective measurements of energy intake or expenditure in association with unpredictability. Therefore, the current study seeks to examine whether the unpredictability schema as measured by a composite score of unpredictability assessments is associated with ad libitum food consumption and eating in the absence of hunger, measured objectively. Furthermore, we will examine the associations between the unpredictability schema and physical activity, resting metabolic rate/respiratory quotient, and glucose trajectories during an oral glucose tolerant test and continuous glucose monitoring in a cohort of healthy participants.

Objectives:

Primary Objective:

  • To determine whether an association exists between unpredictability schema measures (schema/beliefs and childhood experiences as measured by derived from the Child Unpredictability Index, Scale of Unpredictability Beliefs, Unpredictability Schema Scale, and Confusion, Hubbub, and Order Scale and, individually, by scale totals and subscales) and ad libitum food intake.
  • To determine whether an association exists between the unpredictability schema and experience scores and eating in the absence of hunger (as determined by the snack food taste test).

Secondary Objectives:

  • To determine whether an association exists between the unpredictability schema and experience scores and self-reported appetitive eating traits and behavior (as measured by the Eating in the Absence of Hunger Scale, Body Awareness Questionnaire, Reward-Based Eating Drive Scale, U.S. Adult food Security Survey Module, and the Three-Factor Eating Questionnaire).
  • To determine whether an association exists between measures of the unpredictability schema and experience scores and physical activity.
  • To determine whether an association exists between measures of the unpredictability schema and experience scores and resting metabolic rate and RQ.
  • To determine whether an association exists between measures of the unpredictability schema and experience scores and glucose values (CGM and OGTT).
  • To determine whether an association exists between measures of the unpredictability schema and experience scores and telomere length.
  • To determine whether an association exists between measures of the unpredictability schema and experience scores and with gut microbiota composition.
  • To determine whether an association exists between measures of the unpredictability schema and experience scores with countylevel food swamp statistics (i.e., Retail Food Environment Index).

Tertiary Objectives:

  • To determine the associations between measures of early childhood experiences (as measured by an overall composite measure derived by the maternal care/warmth subscale of the Parental Bonding Instrument and physical and emotional neglect subscales from the Childhood Trauma Questionnaire and, individually, by scale totals and subscales) and outcomes outlined in the primary and secondary objectives.
  • To determine whether an association exists between measures of early childhood experiences and the unpredictability schema and experience scores.
  • Examine psychosocial and physiological variables (based on theory and past literature) that may mediate or moderate the relationship between the unpredictability schema and our primary and secondary endpoints.
  • Examine associations of metabolic measures with psychosocial measures (e.g., perceived stress, anhedonia, anxiety, depression, etc.), hormonal endpoints, or future biomarker assayed at a later time point.

Endpoints:

Primary Endpoint:

  • Ad libitum Food Intake (kcal) measured from a buffet meal task.
  • Eating in the absence of hunger (kcal) from a snack food taste test.

Secondary Endpoints:

  • Self-reported scores from the following eating measures: Eating in the Absence of Hunger Scale, Body Awareness Questionnaire, Reward-Based Eating Drive Scale, U.S. Adult food Security Survey Module, and the Three-Factor Eating Questionnaire.
  • Physical activity values and trajectories from the 10-day outpatient research accelerometer assessment.
  • Resting metabolic rate and respiratory quotient values obtained from the metabolic hood.
  • Glucose values and trajectories from fasting labs, OGTT, and 10-day outpatient CGM assessment.
  • Telomere length (t/s ratio)
  • Gut Flora Composition
  • County-level Food Swamp Score (i.e., Retail Food Environment Index)

Tertiary Endpoints:

  • Ad libitum Food Intake (kcal) measured from (1) a buffet meal task and (2) the snack food taste test; Physical activity values and trajectories from the 10-day outpatient research accelerometer assessment; Resting metabolic rate and respiratory quotient values obtained from the metabolic hood; Glucose values and trajectories from fasting labs, OGTT, and 10-day outpatient CGM assessment.
  • Ad libitum Food Intake (kcal) measured from (1) a buffet meal task and (2) the snack food taste test; Physical activity values and trajectories from the 10-day outpatient research accelerometer assessment; Resting metabolic rate and respiratory quotient values obtained from the metabolic hood; Glucose values and trajectories from fasting labs, OGTT, and 10-day outpatient CGM assessment.
  • Unpredictability schema and experience scores
  • Ad libitum Food Intake (kcal) measured from (1) a buffet meal task and (2) the snack food taste test; Physical activity values and trajectories from the 10-day outpatient research accelerometer assessment; Resting metabolic rate and respiratory quotient values obtained from the metabolic hood; Glucose values and trajectories from fasting labs, OGTT, and 10-day outpatient CGM assessment.
  • Plasma hormone, metabolite and protein concentration measured following data collection.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

110

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 60 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Wahrscheinlichkeitsstichprobe

Studienpopulation

The study will enroll healthy, non-pregnant, women and men aged 18-60 years old who are without diabetes from the Greater Phoenix area, Arizona, United States. The study anticipates screening/enrolling 310 participants to achieve a goal of 110 participants completing the study.

Beschreibung

  • INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  • Stated willingness to comply with all study procedures and availability for the duration of the study.
  • 18-60 years of age.
  • Able to read and understand English proficiently (to be able to complete the multiple study questionnaires and instruments).

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

  • Diabetes

    • Fasting glucose >= 126 mg/dl or HbA1c >= 6.5% or
    • Self-reported history of type 1 or type 2 diabetes.

  • Endocrine disorders, such as

    --Self-reported history of Cushing's disease, pituitary disorders, or hypo- and hyperthyroidism

  • TSH <=0.27 or >= 10 uIU/mL

  • Pulmonary disorders

    --Self-reported history of chronic obstructive pulmonary disease or other lung disease that which would limit ability to follow the protocol (investigator judgment)

  • Cardiovascular diseases,

    --Self-reported history of coronary heart disease, heart failure, arrhythmias, and peripheral artery disease that which would limit ability to follow the protocol (investigator judgment)

  • Liver disease,

    • Advanced liver disease (as determined by history, labs, exams, and patient self-report) that which would limit ability to follow the protocol (investigator judgment)
    • AST or ALT elevations > 3 times upper limit of normal

  • Gastrointestinal Surgery

    --Self-reported history of bariatric surgery

  • Renal disease

    • Self-reported history of renal replacement therapy
    • Abnormal kidney function (defined as eGFR <60 mL/min/1.73m^2) determined at screening (eGFR values are computed using the 2021 CKD-epi equation)

  • Central nervous system disease:

    --Including self-reported history of previous history of cerebrovascular accidents, dementia, and neurodegenerative disorders

  • Infectious disease:

    --Self-reported history of active tuberculosis, HIV, chronic coccidiomycosis or other chronic or acute infections

  • For Females: pregnancy, <=6 months postpartum, currently breastfeeding, or on birth control (i.e., ingested, injected or implanted; non-hormonal methods such as copper IUD will be allowed)

  • Measured weight: greater than or equal to 450 lb. (maximum weight allowed on the DXA scanning tables by the manufacturer)

  • Inability to provide informed consent.

  • Self-reported history of psychological conditions including (but not limited to), active psychosis, schizophrenia, eating disorders, or forms of mental incapacity that would be incompatible with safe and successful participation in this study.

  • Current use of medications/dietary supplements/alternative therapies known to alter energy metabolism.

  • Inability to consume provided food during ad libitum food intake or snack food test based on a food allergy or intolerances or diet restrictions.

  • Any disorder not covered by any other exclusion criteria which, in the investigator's and/or team's opinion jeopardizes the safety of the participant or others or would interfere with adherence to the protocol.

  • Alcohol Abuse as defined by >= 8-point score on the Alcohol Use Disorders Identification Test (AUDIT) questionnaire will be an exclusion criterion.

  • Current use of tobacco products that exceed "Very Low Dependence" on the Fagerstrom Test for Nicotine Dependence Tool (score greater than 2) will be an exclusion criterion.

Non-English-speaking subjects as a population will be excluded from participation in this protocol. Primary and secondary hypotheses of the protocol relate to a battery of psychological questionnaires and performances tests which are administered throughout the study. There are currently no validated, translated forms of these questionnaires and tests available; therefore, we will restrict enrollment to English speaking subjects only.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Beobachtungsmodelle: COHORT
  • Zeitperspektiven: PROSPECTIVE

Kohorten und Interventionen

Gruppe / Kohorte
Healthy Volunteer

adults, age 18-60 years

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
To determine whether an association exists between unpredictability schema measures and ad libitum food intake.
Zeitfenster: Day 10

Ad libitum Food Intake (kcal) measured from a buffet meal task.
Day 10
To determine whether an association exists between the unpredictability schema and experience scores and eating in the absence of hunger
Zeitfenster: Day 10

Eating in the absence of hunger (kcal) from a snack food taste test.
Day 10

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
To determine whether an association exists between measures of the unpredictability schema and experience scores and physical activity.
Zeitfenster: Day 10

Physical activity values and trajectories from the 10-day outpatient research accelerometer assessment
Day 10
To determine whether an association exists between measures of the unpredictability schema and experience scores and resting metabolic rate and RQ.
Zeitfenster: Day 10

Resting metabolic rate and respiratory quotient values obtained from the metabolic hood.
Day 10
To determine whether an association exists between measures of the unpredictability schema and experience scores and glucose values (CGM and OGTT)
Zeitfenster: Day 10

Glucose values and trajectories from fasting labs, OGTT, and 10-day outpatient CGM assessment, including mean, standard deviation, area-under-the-curve, and estimated a1c
Day 10
To determine whether an association exists between measures of the unpredictability schema and experience scores and telomere length
Zeitfenster: Day 10

Telomere length (t/s ratio)
Day 10
To determine whether an association exists between measures of the unpredictability schema and experience scores and with gut microbiota composition.
Zeitfenster: Day 10

Gut Flora Composition
Day 10
To determine whether an association exists between measures of the unpredictability schema and experience scores with county-level food swamp statistics (i.e., Retail Food Environment Index).
Zeitfenster: Day 10

County-level Food Swamp Score (i.e., Retail Food Environment Index)
Day 10
To determine whether an association exists between the unpredictability schema and experience scores and self-reported appetitive eating traits and behavior
Zeitfenster: Day 10

Self-reported scores from the following eating measures: Eating in the Absence of Hunger Scale, Body Awareness Questionnaire, Reward-Based Eating Drive Scale, U.S. Adult food Security Survey Module, and the Three-Factor Eating Questionnaire.
Day 10

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Ermittler

  • Hauptermittler: Tomas Cabeza De Baca, Ph.D., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

8. November 2026

Primärer Abschluss (Geschätzt)

30. Januar 2027

Studienabschluss (Geschätzt)

30. Januar 2027

Studienanmeldedaten

Zuerst eingereicht

13. November 2024

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

14. November 2024

Zuerst gepostet (Tatsächlich)

15. November 2024

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

3. November 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

2. November 2026

Zuletzt verifiziert

17. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 10001980
  • 001980-DK

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NEIN

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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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