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A Dissonance-Based Obesity Intervention

2. juni 2022 oppdatert av: Sylvia Herbozo, University of Illinois at Chicago

Enhanced Project Health: A Dissonance-Based Intervention for Obesity in Young Adults

This project will examine the feasibility and acceptability of Enhanced Project Health, a dissonance-based obesity intervention, and whether this intervention results in significantly greater reductions in weight and improvements in lifestyle behaviors than an assessment only condition. Participants will be young adults enrolled in college.

Studieoversikt

Status

Avsluttet

Forhold

Detaljert beskrivelse

Approximately 34% of college students are overweight/obese. However, few behavioral weight loss (BWL) interventions have been developed for young adults in college. Research suggests that standard BWL interventions are not addressing the needs of young adults as they have shown poorer retention rates and weight loss compared to older adults in BWL trials. Standard BWL interventions are also time-intensive and are not conducive to inexpensive dissemination.

The primary aim of this project is to examine the feasibility and acceptability of Enhanced Project Health, a dissonance-based obesity intervention for young adults enrolled in college. Enhanced Project Health is based on Project Health, a dissonance-based obesity prevention program, which has been shown to significantly decrease weight gain and future overweight/obesity onset compared to a matched intervention and minimal intervention control condition in young adults. The current intervention was expanded to consist of eight weekly group sessions and to address sleep, in addition to diet and physical activity. The secondary aim is to test the hypothesis that Enhanced Project Health will result in significantly greater reductions in weight and improvements in lifestyle behaviors compared to an assessment only condition.

Studietype

Intervensjonell

Registrering (Faktiske)

7

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Illinois
      • Chicago, Illinois, Forente stater, 606012
        • Neuropsychiatric Institute, University of Illinoist at Chicago

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 25 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. Young adults of ages 18 to 25.
  2. Enrolled as a college student.
  3. Body mass index of 25 or more (overweight/obese) based on measured height and weight.

Exclusion Criteria:

  1. Diagnosis of bulimia nervosa according to DSM-5 criteria.
  2. Diagnosis of obstructive sleep apnea.
  3. Participation in interventions for weight loss or disordered eating behaviors.
  4. Current use of prescription drugs for weight loss or disordered eating behaviors.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Dissonance-based obesity intervention
Participants in this arm will receive Enhanced Project Health.
A dissonance-based obesity intervention consisting of eight weekly groups sessions (1.5 hours).
Ingen inngripen: Assessment Only
Participants in this arm will only complete the baseline assessment and 2 month assessment. They will not receive Enhanced Project Health.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of eligible young adults that agree to participate in the study
Tidsramme: Up to 1 month
This will be defined as a percentage of young adults that agree to participate in study out of the young adults screened for the study.
Up to 1 month
Time for recruitment
Tidsramme: Up to 1 month
This will be defined as time (weeks and days) from initial contact with research staff to randomization into the study.
Up to 1 month
Attendance rate of participants
Tidsramme: Assessed at 2 months
This will be defined as the percentage of participants attending 75% of the group sessions.
Assessed at 2 months
Retention rate of participants
Tidsramme: Assessed at 2 months
This will be defined as the percentage of participants remaining in the study at the post-intervention assessment.
Assessed at 2 months
Program Evaluation Questionnaire - Each Group Session
Tidsramme: Assessed from week 1 to week 8

This questionnaire was developed for this study. It will assess the acceptability of the intervention and will be administered at the end of each group session. Participants will be asked to rate the usefulness of the session on one item with a scale ranging from 1 to 5. Total scores range from 1 to 5. Higher scores indicate more usefulness.

Participants will also be asked to respond to open-ended questions about each group session. These questions will assess the most favorable aspects, least favorable aspects, and areas of improvements. Responses will be coded using a variation of the long table approach emphasizing frequency, specificity, emotion, and extensiveness. Codes will be examined to identify themes.

Assessed from week 1 to week 8
Program Evaluation Questionnaire - Overall Program
Tidsramme: Assessed at week 8
This questionnaire was developed for this study. It will assess the program with regard to effectiveness and satisfaction as well as characteristics of the group leaders (clarity, knowledge, experience, respect) using a scale ranging from 1 to 5. Total scores range from 8 to 40. Higher scores indicate more favorable responses. This questionnaire will be administered at the end of the last group session.
Assessed at week 8

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Body Mass Index (kg/m^2)
Tidsramme: Baseline to 2 months
Body Mass Index will be calculated using measured weight and height (kg/m^2)
Baseline to 2 months
International Physical Activity Questionnaire-Short Form (IPAQ-S)
Tidsramme: Baseline to 2 months
The International Physical Activity Questionnaire-Short Form will assess walking, moderate-intensity activity, and vigorous-intensity activity. The scores for each type of physical activity are converted to MET-minutes/week as defined by the following: Walking MET-minutes/week = 3.3 * walking minutes * walking days; Moderate MET-minutes/week = 4.0 * moderate-intensity activity minutes * moderate days; Vigorous MET-minutes/week = 8.0 * vigorous-intensity activity minutes * vigorous-intensity days; Total physical activity MET-minutes/week = sum of Walking + Moderate + Vigorous MET-minutes/week scores. The total score will be computed by summing the duration (in minutes) and frequency (days) of each activity. Higher duration and frequency indicate more engagement in physical activity. The pattern of physical activity can also be classified as low, moderate, or high based on the total score.
Baseline to 2 months
Actigraph GT3XP-BTLE
Tidsramme: Baseline to 2 months
An accelerometer will record physical activity for a 1 week period
Baseline to 2 months
Pittsburgh Sleep Quality Index (PSQI)
Tidsramme: Baseline to 2 months
The Pittsburgh Sleep Quality Index will assess the quality and patterns of sleep using a scale ranging from 0 to 3. Total scores range from 8 to 57. Higher scores indicate greater sleep disturbances.
Baseline to 2 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Sylvia Herbozo, Ph.D., University of Illinois at Chicago

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. september 2021

Primær fullføring (Faktiske)

18. februar 2022

Studiet fullført (Faktiske)

18. februar 2022

Datoer for studieregistrering

Først innsendt

22. august 2019

Først innsendt som oppfylte QC-kriteriene

22. august 2019

Først lagt ut (Faktiske)

28. august 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. juni 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. juni 2022

Sist bekreftet

1. juni 2022

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 2019-0892

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Nei

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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