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Text Messaging for Weight Loss

9 novembre 2015 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Obésité

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

Phase

N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

États-Unis
- Texas
  - Houston, Texas, États-Unis, 77030
    - UT Physicians - Internal Medicine

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

21 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Objectif principal: Traitement
Répartition: Randomisé
Modèle interventionnel: Affectation parallèle
Masquage: Aucun (étiquette ouverte)

Nombre de bras

Armes et Interventions

Groupe de participants / Bras	Intervention / Traitement
Expérimental: 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	Comportemental: Personal feedback
Comparateur actif: 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.	Comportemental: one way text

Groupe de participants / Bras

Intervention / Traitement

Expérimental: 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

Comportemental: Personal feedback

Comparateur actif: 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.

Comportemental: one way text

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Change in weight from baseline Délai: baseline and 6 months	Weight in a lightweight hospital gown with no shoes (calibrated digital scale)	baseline and 6 months

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
Change in diet measured by Fruit and Vegetable Screener (NCI) Délai: baseline and 6 months		baseline and 6 months
Change in physical activity as measured by Paffenbarger physical activity questionnaire Délai: baseline and 6 months		baseline and 6 months
Change in social support as measured by Weight Management Support Inventory Délai: 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) Délai: baseline and 6 months	Measures the individual's self-rated executive functioning.	baseline and 6 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

The University of Texas Health Science Center, Houston

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 octobre 2012

Achèvement primaire (Réel)

1 mars 2015

Achèvement de l'étude (Réel)

1 mars 2015

Dates d'inscription aux études

Première soumission

7 novembre 2012

Première soumission répondant aux critères de contrôle qualité

21 novembre 2012

Première publication (Estimation)

29 novembre 2012

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

10 novembre 2015

Dernière mise à jour soumise répondant aux critères de contrôle qualité

9 novembre 2015

Dernière vérification

1 novembre 2015

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

HSC-MS-12-0571

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Text Messaging for Weight Loss