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mDiet: A Text Message Intervention for Weight Loss

3. desember 2014 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

318

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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Studiesteder

  • Forente stater
    • California
      • La Jolla, California, Forente stater, 92037-0811
        • UCSD, Atkinson Hall, 3rd Floor

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

21 år til 60 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Atferdsmessig: 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.
Eksperimentell: 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.
Atferdsmessig: 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 inngripen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

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Sponsor

University of California, San Diego

Publikasjoner og nyttige lenker

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Generelle publikasjoner

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

1. mai 2010

Primær fullføring (Faktiske)

1. juni 2014

Studiet fullført (Faktiske)

1. juni 2014

Datoer for studieregistrering

Først innsendt

26. juli 2010

Først innsendt som oppfylte QC-kriteriene

27. juli 2010

Først lagt ut (Anslag)

28. juli 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

5. desember 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. desember 2014

Sist bekreftet

1. desember 2014

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

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