Clinical trial NCT03254940: Charge: A Text Messaging-based Weight Loss Intervention
Official title: Charge: Optimizing a Standalone Text Messaging-Based Weight Loss Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Obesity
Keywords: text message
digital health
weight loss
personalized
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2017-08-21
Enrollment: 534
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: The investigators will use a full factorial design to randomize participants to experimental conditions that reflect the texting intervention components: motivational messaging (self- vs expert-generated), texting frequency (daily vs weekly), reminders (one reminder v. multiple reminders), feedback type (summary score v. specific feedback) and comparison unit (to self v. to a group of people). The full factorial design is power efficient, logistically feasible (because we manipulate conditions using technology) and will allow the investigators to examine the most important main and interaction effects among components.
Primary purpose: TREATMENT

Brief summary: This study evaluates different versions of a text messaging-based app for weight loss. This study will place participants to 1 of 32 experimental conditions that reflect different texting components and levels. Participants will be randomized to a condition. The investigators will recruit 448 adults into a 6-month weight loss program, with an additional follow-up 6-months after the intervention ends.

Detailed description: Standalone text messaging-based weight loss treatments are scalable and can achieve population reach. However, these interventions are also modular; they can be delivered independently to maximize cost-effectiveness or combined with other approaches (e.g. provider counseling) to maximize outcomes. This study is a 12-month experimental trial among 448 adults with obesity. All participants will receive a core 6-month weight loss texting intervention that includes tailored behavior change goals, interactive self-monitoring, automated feedback, and skills training. Participants will be randomly assigned to 1 of 32 different experimental conditions.

Eligibility criteria: Inclusion Criteria:

* males and females aged 18-65 years
* participants have English language proficiency
* participants have a BMI between 25-40 kg/m2
* Participants will own a smartphone
* Participants will be willing to receive multiple text messages daily.

Exclusion Criteria:

* prior or planned bariatric surgery
* psychiatric hospitalization in past 12 months
* pregnancy, nursing, or planned pregnancy
* history of a cardiovascular event
* history of an eating disorder
* history of a condition (e.g., end stage renal disease, cancer, schizophrenia) or use of medications (e.g., lithium, steroids, anti-psychotics) that would affect weight measurement, for which weight loss is contraindicated, or might promote weight change
* current participation in a weight loss trial and/or recent weight loss \> 10%
* investigator discretion for safety reasons

Primary outcomes:
measure: Average Weight Change
timeFrame: baseline, 6 months
Secondary outcomes:
measure: Change in Diet
timeFrame: baseline, 6 months
measure: Average Change in Physical Activity
timeFrame: baseline, 6 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Bishop-MacDermott Family Professor of Psychology, Global Health & Medicine
name: Gary G Bennett, PhD
role: PRINCIPAL_INVESTIGATOR
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