Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

mDiet: A Text Message Intervention for Weight Loss

3. december 2014 opdateret af: Kevin Patrick, MD, MS, University of California, San Diego
The purpose of the National Cancer Institute (NCI) funded randomized controlled study is to develop and evaluate a text message (SMS) based weight loss intervention to 309 overweight or moderately obese English and Spanish speaking adults ages 21 - 60. The investigators propose that participants randomized to the intervention arms will lose significantly more weight than those participants randomized to the control group.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The SMS based intervention will be developed through formative research including focus groups, cognitive interviews, and a pilot test of a Spanish version of mDIET. The focus groups will be conducted with both English and Spanish speaking men and women to 1) learn more about the content areas to be addressed in the intervention including physical activity and sedentary behaviors to expand on previous research; 2) learn more about assessing equivalence and compatibility in intervention messages in English and Spanish; 3) identify the most culturally and linguistically appropriate messages; 4) assess text message use; 5) identify factors that influence food and physical activity decisions; and 6) identify health messages that Latinos see as most understandable, credible, and persuasive, cognitive interviews, and a pilot test of a Spanish version of mDIET. The cognitive interviews will be conducted in Spanish and will help inform translation of study materials (text messages and measures) from English to Spanish. An 8-week pilot test of the Latino (Spanish language) mDIET will be conducted to ensure that the text messages and SMS system works as expected in terms of usability and acceptability.

The randomized controlled trial will be a 12-month intervention with 309 study participants. Participants will be randomized to one of three groups: SMS-only, SMS plus phone counseling, and a control group (Details of the study arms are discussed in another section). The goals of the intervention groups (SMS-only and SMS plus phone counseling) include: 5% weight loss, 500 k/cal per day deficit through reduced caloric intake and increased energy expenditure, 12,00 steps through the use of a pedometer, and a reduction in sedentary behaviors. Participants will receive daily text messages, self-monitoring tools, and brief health promotion printed or wed materials on physical activity, nutrition, or other weight loss related topics. Participants will complete physiological and survey measures at baseline, 6 months, and 12 months to assess weight (BMI), physical activity and diet behaviors, psychosocial behaviors, environmental factors, and exposure and satisfaction with the program.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

318

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • California
      • La Jolla, California, Forenede Stater, 92037-0811
        • UCSD, Atkinson Hall, 3rd Floor

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

21 år til 60 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Are 21 - 60 years
  • Are overweight or moderately obese with a BMI between 27.0 - 39.9
  • Have a cell phone that is capable of sending and receiving text and picture messages
  • Have a permanent residence in San Diego County and intend to stay over the entire study duration
  • Speak and read English or Spanish
  • Are willing to attend all (3) measurement assessments at the research office
  • Provide assent and have a legal guardian that will participate and provide parental permission/consent

Exclusion Criteria:

  • Have any of the following conditions: pulmonary, cardiovascular, or musculoskeletal problems that would limit the ability to comply with moderate intensity physical activity (i.e. brisk walking)
  • Are pregnant or intend to become pregnant during the study period
  • Have a history of substance abuse
  • Have a psychiatric disorder that would impair compliance with the study protocol
  • Are using weight loss medications or supplements
  • Are currently involved in another weight loss study or program

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

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

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: SMS Only
The SMS only group will receive hints, tips, strategies, and questions related to weight loss behaviors, physical activity, nutrition, and motivation. The messages will be "pushed" to participants (i.e. no response needed) and "pulled" from participants (i.e. response is needed). The SMS only group will also receive a brief printed or web based outline on weight loss resources and information.
Adfærdsmæssigt: mDiet
The goals of the intervention groups (SMS-only and SMS plus phone counseling) include: 5% weight loss, 500 k/cal per day deficit through reduced caloric intake and increased energy expenditure, 12,00 steps through the use of a pedometer, and a reduction in sedentary behaviors. Participants will receive daily "pushed" and "pulled" text messages, self-monitoring tools, and brief health promotion printed or wed materials on physical activity, nutrition, or other weight loss related topics.
Eksperimentel: SMS + Phone Counseling
This group will receive hints, tips, strategies, and questions related to weight loss behaviors, physical activity, nutrition, and motivation. The messages will be "pushed" to participants (i.e. no response needed) and "pulled" from participants (i.e. response is needed). The group will also receive monthly counseling calls from a Health Coach to discuss barriers and solutions and will receive a brief printed or web based outline on weight loss resources and information.
Adfærdsmæssigt: mDiet
The goals of the intervention groups (SMS-only and SMS plus phone counseling) include: 5% weight loss, 500 k/cal per day deficit through reduced caloric intake and increased energy expenditure, 12,00 steps through the use of a pedometer, and a reduction in sedentary behaviors. Participants will receive daily "pushed" and "pulled" text messages, self-monitoring tools, and brief health promotion printed or wed materials on physical activity, nutrition, or other weight loss related topics.
Ingen indgriben: Control
The Control group will receive a binder with an attractive set of Standard Print Materials related to weight loss that is comparable to what one would receive from community resources such as libraries, magazines and national non-profit or governmental organizations such as 5-A Day, American Heart Association and the like.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Weight Loss
Tidsramme: 12 months
To evaluate differences from baseline in percent weight loss at 12 months. We hypothesize that, compared to the usual care Standard Print condition differences in weight loss will be significant in both the SMS only (SMS = short message service or text message) and SMS+Phone intervention groups.
12 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Intervention Effects
Tidsramme: 12 months
To assess the intervention effects on weight loss by study group, diet, physical activity and sedentary behaviors, quality of life, and depression
12 months
Weight Loss Between Intervention Arms
Tidsramme: 12 months
To assess differences in weight loss between the 2 intervention arms (SMS only and SMS plus phone counseling)
12 months
Intervention Satisfaction and Exposure
Tidsramme: 12 months
To assess the level of satisfaction and use of the intervention components (SMS, phone counseling)
12 months

Samarbejdspartnere og efterforskere

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

Sponsor

University of California, San Diego

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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. maj 2010

Primær færdiggørelse (Faktiske)

1. juni 2014

Studieafslutning (Faktiske)

1. juni 2014

Datoer for studieregistrering

Først indsendt

26. juli 2010

Først indsendt, der opfyldte QC-kriterier

27. juli 2010

Først opslået (Skøn)

28. juli 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

5. december 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. december 2014

Sidst verificeret

1. december 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • R01CA138730 (U.S. NIH-bevilling/kontrakt)

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 .

Abonner