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The Comparison of a Technology-Based System and an In-Person Behavioral Weight Loss Intervention

4. august 2015 opdateret af: John M. Jakicic, PhD
The primary aim of this study is to compare the changes in body weight between a technology-based system, an in-person behavioral weight loss intervention, and a combination of both during a 12 month behavioral weight loss intervention in adults. Sedentary, healthy overweight and obese adults will be recruited to participate. Assessments will be conducted at 0, 6, and 12 months. This is a randomized trial in which participants will be randomized to one of three groups: standard behavioral weight loss (SBWL), standard behavioral weight loss plus technology (SBWL+TECH), and technology alone alone (TECH).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

51

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15260
        • University of Pittsburgh

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 55 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • ages of 21-55 years
  • Body mass index (BMI) between 25-39.9 kg/m2

Exclusion Criteria:

  • Currently pregnant, pregnant in the last 6 months, or plan on becoming pregnant in the next 6 months.
  • Currently participating in regular exercise for over 60 minutes/week.
  • Taking any medications that affect body weight or metabolism (e.g. synthroid).
  • Have any physical limitations that would prevent exercise.
  • Currently being treated for coronary heart disease, diabetes mellitus, hypertension, or cancer.
  • Have a history of myocardial infarction or other heart-related surgeries.
  • Have a resting systolic blood pressure > 150 mmHg or diastolic blood pressure of > 100 mmHg or currently taking any medications that affect blood pressure or heart rate (e.g. beta blockers).
  • Currently enrolled in a commercial weight loss program, participating in another weight loss study, or in a weight loss study in the last 12 months.
  • Have lost > 5% of current body weight in the past 6 months.
  • Currently being treated for any psychological problems or taking any psychotropic medication.
  • Currently do not have access to a computer and the Internet that can be used for this study. This requires a PC computer, the ability to load software for the technology system, an existing internet connection provided by the participant, and a dedicated USB port to allow the armband from the technology system to be connected to the computer for the download of information.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Standard weight loss intervention
Adfærdsmæssigt: Standard weight loss intervention
In-person weight loss sessions, dietary intake prescription of 1200-1500 kcal per day, exercise progressing to 300 minutes per week.
Eksperimentel: Standard weight loss intervention plus technology
Adfærdsmæssigt: Standard weight loss intervention plus technology
In-person weight loss sessions, dietary intake prescription of 1200-1500 kcal per day, exercise progressing to 300 minutes per week, plus technology to provide real-time feedback on energy expenditure, plus a website to log dietary intake.
Eksperimentel: Technology only
Adfærdsmæssigt: Technology only
One intervention telephone call per month, dietary intake prescription of 1200-1500 kcal per day, exercise progressing to 300 minutes per week, plus technology to provide real-time feedback on energy expenditure, plus a website to log dietary intake.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
weight
Tidsramme: change from 0 to 6 months
Body weight will be assessed on a digital scale to assess change in body weight over the intervention period.
change from 0 to 6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
cardiorespiratory fitness
Tidsramme: 0, 6, 12, months
A graded exercise test on a treadmill along with indirect calorimetry will be used to measure cardiorespiratory fitness. This will provide a measure of oxygen consumption and metabolic equivalents of work at the time of test termination.
0, 6, 12, months
body composition
Tidsramme: 0, 6, 12 months
Body composition will be assessed using dual energy X-ray absorptiometry (DXA). This will provide a measure of lean body mass, fat mass, bone mineral content, and percent body fat.
0, 6, 12 months
physical activity
Tidsramme: 0, 6, 12 months
A questionnaire and a portable device worn on the upper arm will be used to measure and quantify energy expenditure from physical activity.
0, 6, 12 months
dietary intake
Tidsramme: 0, 6, 12 months
A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed.
0, 6, 12 months
psychosocial and behavioral measures
Tidsramme: 0, 6, 12 months
Questionnaires will be used to assess self-efficacy for weight loss and physical activity, barriers to physical activity and weight loss, expected outcomes resulting from physical activity and weight loss, perceived body image, depressive symptomotology, weight history, dietary disinhibition and restraint, and behaviors typically related to weight loss (e.g., self-weighing, meal planning, etc.).
0, 6, 12 months
Weight change
Tidsramme: weight at 0, 6, and 12 months
Body weight measured on a digital scale
weight at 0, 6, and 12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

John M. Jakicic, PhD

Efterforskere

  • Studieleder: Steve Verba, MS, University of Pittsburgh

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2009

Primær færdiggørelse (Faktiske)

1. september 2010

Studieafslutning (Faktiske)

1. september 2010

Datoer for studieregistrering

Først indsendt

25. maj 2010

Først indsendt, der opfyldte QC-kriterier

28. maj 2010

Først opslået (Skøn)

2. juni 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

5. august 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. august 2015

Sidst verificeret

1. august 2015

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PRO09040121

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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