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Text Messaging for Weight Loss

9 november 2015 bijgewerkt door: Kevin Hwang, MD, The University of Texas Health Science Center, Houston

Text Messaging for Weight Loss in Primary Care Patients

Overweight and obese adults recruited from the primary care setting (n=150) will be enrolled in a 6-month randomized trial of the INTERVENTION versus CONTROL. Both groups will receive usual medical care, printed materials, and educational text messages. The INTERVENTION group will also receive personalized coaching and feedback, as well as peer support, via text message.

The investigators hypothesize that compared to those in the Control group, patients in the Intervention group will lose more weight and demonstrate more favorable changes in fruit and vegetable intake, exercise, and social support for weight loss.

Studie Overzicht

Toestand

Voltooid

Conditie

Obesitas

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

Fase

Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Verenigde Staten
- Texas
  - Houston, Texas, Verenigde Staten, 77030
    - UT Physicians - Internal Medicine

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

21 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

Approved to participate by PCP (Patients with diabetes, hypertension, or dyslipidemia will be eligible if approved by their PCP)
Age ≥ 21 years
Body mass index (BMI) 25 to 45 kg/m2 and weight ≤ 400 pounds
Goal of losing weight (not just maintain weight)
Willing to change diet, physical activity in order to lose weight.
Currently uses text messaging in English on mobile phone
Willing to use send and receive text messages for this study without direct compensation for cost of messages (general compensation for study participation will be provided)
Have a scale at home for self-monitoring weight
Fluent in English (speak, read, write)
Commit to return for follow-up weight at 6 months regardless of amount of weight lost

Exclusion Criteria:

Involuntary or voluntary weight loss of ≥ 5% body weight in previous 6 months
Participating in research project involving weight loss, exercise, or dietary modification in the previous 6 months
Any of the following medical conditions which could affect weight or for which weight loss is contraindicated
- End-stage liver disease
- End-stage kidney disease
- Cancer within previous 2 years (except non-melanoma skin cancer)
Myocardial infarction, stroke, or transient ischemic attack within previous 6 months
Unstable angina
Severe arthritis or other medical conditions which would prevent brisk walking
Schizophrenia
Hospitalization for psychiatric problems during the prior 12 months.
Current use or anticipated future use (during 6 month study) of medications that could cause weight loss:
- phentermine
- orlistat (prescription Xenical or OTC Alli)
- topiramate
- buprioprion
- exenatide (Byetta)
- liraglutide (Victoza)
Prior bariatric surgery or plans for bariatric surgery in next 6 months
Pregnant or breast feeding within the previous 6 months
Planning to become pregnant in next 6 months
Consumes > 14 alcoholic drinks per week
Current use of illicit drugs
Planning to move out of the area in the next 6 months
Another member of household or a close contact is participating in the study

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Primair doel: Behandeling
Toewijzing: Gerandomiseerd
Interventioneel model: Parallelle opdracht
Masker: Geen (open label)

Aantal wapens

Wapens en interventies

Deelnemersgroep / Arm	Interventie / Behandeling
Experimenteel: Personal feedback This arm will receive all intervention components of Active Comparator group, plus the following: Text messages to prompt participant to reply with self-monitoring entries Human coach uses system to send personalized text messages with feedback on self-monitoring entries	Gedragsmatig: Personal feedback
Actieve vergelijker: One Way Text Printed handouts from the "Aim for a Healthy Weight" booklet, which is published by National Heart, Lung, and Blood Institute and is frequently included in control conditions in primary care-based weight loss studies. Other handouts will discuss the use of prepackaged foods as well as setting goals for calorie intake, physical activity, and weight loss. One to three text messages per week, based on topics from "Aim for a Healthy Weight" and other sources. The text messages will be pre-scheduled, automated, non-tailored, and "one-way" (no reply will be requested). The total dose of contact will be low because each text message is limited to 160 characters. The condition is comparable in intensity to control conditions in other weight loss trials in the primary care setting. Usual medical care from the PCP. Education on symptoms of hypoglycemia, hypotension, and cardiovascular disease, with instructions to contact their PCP in the event of those symptoms.	Gedragsmatig: one way text

Deelnemersgroep / Arm

Interventie / Behandeling

Experimenteel: Personal feedback

This arm will receive all intervention components of Active Comparator group, plus the following:

Text messages to prompt participant to reply with self-monitoring entries
Human coach uses system to send personalized text messages with feedback on self-monitoring entries

Gedragsmatig: Personal feedback

Actieve vergelijker: One Way Text

Printed handouts from the "Aim for a Healthy Weight" booklet, which is published by National Heart, Lung, and Blood Institute and is frequently included in control conditions in primary care-based weight loss studies.
Other handouts will discuss the use of prepackaged foods as well as setting goals for calorie intake, physical activity, and weight loss.
One to three text messages per week, based on topics from "Aim for a Healthy Weight" and other sources. The text messages will be pre-scheduled, automated, non-tailored, and "one-way" (no reply will be requested). The total dose of contact will be low because each text message is limited to 160 characters. The condition is comparable in intensity to control conditions in other weight loss trials in the primary care setting.
Usual medical care from the PCP.
Education on symptoms of hypoglycemia, hypotension, and cardiovascular disease, with instructions to contact their PCP in the event of those symptoms.

Gedragsmatig: one way text

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Change in weight from baseline Tijdsspanne: baseline and 6 months	Weight in a lightweight hospital gown with no shoes (calibrated digital scale)	baseline and 6 months

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Change in diet measured by Fruit and Vegetable Screener (NCI) Tijdsspanne: baseline and 6 months		baseline and 6 months
Change in physical activity as measured by Paffenbarger physical activity questionnaire Tijdsspanne: baseline and 6 months		baseline and 6 months
Change in social support as measured by Weight Management Support Inventory Tijdsspanne: baseline and 6 months	A validated questionnaire with 4 domains of social support for weight control (emotional, instrumental, informational, and appraisal)	baseline and 6 months
Change in executive function as measured by Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) Tijdsspanne: baseline and 6 months	Measures the individual's self-rated executive functioning.	baseline and 6 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

The University of Texas Health Science Center, Houston

Onderzoekers

Hoofdonderzoeker: Kevin O. Hwang, MD, The University of Texas Health Science Center, Houston

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 oktober 2012

Primaire voltooiing (Werkelijk)

1 maart 2015

Studie voltooiing (Werkelijk)

1 maart 2015

Studieregistratiedata

Eerst ingediend

7 november 2012

Eerst ingediend dat voldeed aan de QC-criteria

21 november 2012

Eerst geplaatst (Schatting)

29 november 2012

Updates van studierecords

Laatste update geplaatst (Schatting)

10 november 2015

Laatste update ingediend die voldeed aan QC-criteria

9 november 2015

Laatst geverifieerd

1 november 2015

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

HSC-MS-12-0571

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Text Messaging for Weight Loss