Charge: A Text Messaging-based Weight Loss Intervention

April 9, 2025 updated by: Duke University

Charge: Optimizing a Standalone Text Messaging-Based Weight Loss Intervention

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
534

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27708
        • Duke University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm 1: WT-SM-OR-SS-CS
Charge: weekly tracking, self-generated motivational messages, one reminder, summary score, compare to self
Behavioral: Charge
Text messaging-based study to determine effect of different components on weight loss.
Experimental: Arm 2: WT-SM-OR-SS-CG
Charge: weekly tracking, self-generated motivational messages, one reminder, summary score, compare to group
Behavioral: Charge
Text messaging-based study to determine effect of different components on weight loss.
Experimental: Arm 3: WT-SM-OR-SF-CS
Charge: weekly tracking, self-generated motivational messages, one reminder, specific goal feedback, compare to self
Behavioral: Charge
Text messaging-based study to determine effect of different components on weight loss.
Experimental: Arm 4: WT-SM-OR-SF-CG
Charge: weekly tracking, self-generated motivational messages, one reminder, specific goal feedback, compare to group
Behavioral: Charge
Text messaging-based study to determine effect of different components on weight loss.
Experimental: Arm 5: WT-SM-MR-SS-CS
Charge: weekly tracking, self-generated motivational messages, multiple reminders, summary score, compare to self.
Behavioral: Charge
Text messaging-based study to determine effect of different components on weight loss.
Experimental: Arm 6: WT-SM-MR-SS-CG
Charge: weekly tracking, self-generated motivational messages, multiple reminders, summary score, compare to group.
Behavioral: Charge
Text messaging-based study to determine effect of different components on weight loss.
Experimental: Arm 7: WT-SM-MR-SF-CS
Charge: weekly tracking, self-generated motivational messages, multiple reminders, specific feedback, compare to self
Behavioral: Charge
Text messaging-based study to determine effect of different components on weight loss.
Experimental: Arm 8: WT-SM-MR-SF-CG
Charge: weekly tracking, self-generated motivational messages, multiple reminders, specific feedback, compare to group
Behavioral: Charge
Text messaging-based study to determine effect of different components on weight loss.
Experimental: Arm 9: WT-EM-OR-SS-CS
Charge: weekly tracking, expert-generated motivational messages, one reminder, summary score, compare to self
Behavioral: Charge
Text messaging-based study to determine effect of different components on weight loss.
Experimental: Arm 10: WT-EM-OR-SS-CG
Charge: weekly tracking, expert-generated motivational messages, one reminder, summary score, compare to group
Behavioral: Charge
Text messaging-based study to determine effect of different components on weight loss.
Experimental: Arm 11: WT-EM-OR-SF-CS
Charge: weekly tracking, expert-generated motivational messages, one reminder, specific goal feedback, compare to self
Behavioral: Charge
Text messaging-based study to determine effect of different components on weight loss.
Experimental: Arm 12: WT-EM-OR-SF-CG
Charge: weekly tracking, expert-generated motivational messages, one reminder, specific goal feedback, compare to group.
Behavioral: Charge
Text messaging-based study to determine effect of different components on weight loss.
Experimental: Arm 13: WT-EM-MR-SS-CS
Charge: weekly tracking, expert-generated motivational messages, multiple reminders, summary score, compare to self
Behavioral: Charge
Text messaging-based study to determine effect of different components on weight loss.
Experimental: Arm 14: WT-EM-MR-SS-CG
Charge: weekly tracking, expert-generated motivational messages, multiple reminders,summary score, compare to group
Behavioral: Charge
Text messaging-based study to determine effect of different components on weight loss.
Experimental: Arm 15: WT-EM-MR-SF-CS
Charge: weekly tracking, expert-generated motivational messages, multiple reminders, specific goal feedback, compare to self
Behavioral: Charge
Text messaging-based study to determine effect of different components on weight loss.
Experimental: Arm 16: WT-EM-MR-SF-CG
Charge: weekly tracking, expert-generated motivational messages, multiple reminders, specific goal feedback, compare to group
Behavioral: Charge
Text messaging-based study to determine effect of different components on weight loss.
Experimental: Arm 17: DT-SM-OR-SS-CS
Charge: daily tracking, self-generated motivational messages, one reminder, summary score, compare to self.
Behavioral: Charge
Text messaging-based study to determine effect of different components on weight loss.
Experimental: Arm 18: DT-SM-OR-SS-CG
Charge: daily tracking, self-generated motivational messages, one reminder, summary score, compare to group
Behavioral: Charge
Text messaging-based study to determine effect of different components on weight loss.
Experimental: Arm 19: DT-SM-OR-SF-CS
Charge: daily tracking, self-generated motivational messages, one reminder, specific goal feedback, compare to self.
Behavioral: Charge
Text messaging-based study to determine effect of different components on weight loss.
Experimental: Arm 20: DT-SM-OR-SF-CG
Charge: daily tracking, self-generated motivational messages, one reminder, specific goal feedback, compare to group
Behavioral: Charge
Text messaging-based study to determine effect of different components on weight loss.
Experimental: Arm 21: DT-SM-MR-SS-CS
Charge: daily tracking, self-generated motivational messages, multiple reminders, summary score, compare to self
Behavioral: Charge
Text messaging-based study to determine effect of different components on weight loss.
Experimental: Arm 22: DT-SM-MR-SS-CG
Charge: daily tracking, self-generated motivational messages, multiple reminders, summary score, compare to group.
Behavioral: Charge
Text messaging-based study to determine effect of different components on weight loss.
Experimental: Arm 23: DT-SM-MR-SF-CS
Charge: daily tracking, self-generated motivational messages, multiple reminders, specific goal feedback, compare to self.
Behavioral: Charge
Text messaging-based study to determine effect of different components on weight loss.
Experimental: Arm 24: DT-SM-MR-SF-CG
Charge: daily tracking, self-generated motivational messages, multiple reminders, specific goal feedback, compare to group
Behavioral: Charge
Text messaging-based study to determine effect of different components on weight loss.
Experimental: Arm 25: DT-EM-OR-SS-CS
Charge: daily tracking, expert-generated motivational messages, one reminder, summary score, compare to self
Behavioral: Charge
Text messaging-based study to determine effect of different components on weight loss.
Experimental: Arm 26: DT-EM-OR-SS-CG
Charge: daily tracking, expert-generated motivational messages, one reminder, summary score, compare to group
Behavioral: Charge
Text messaging-based study to determine effect of different components on weight loss.
Experimental: Arm 27: DT-EM-OR-SF-CS
Charge: daily tracking, expert-generated motivational messages, one reminder, specific goal feedback, compare to self
Behavioral: Charge
Text messaging-based study to determine effect of different components on weight loss.
Experimental: Arm 28: DT-EM-OR-SF-CG
Charge: daily tracking, expert-generated motivational messages, one reminder, specific goal feedback, compare to group
Behavioral: Charge
Text messaging-based study to determine effect of different components on weight loss.
Experimental: Arm 29: DT-EM-MR-SS-CS
Charge: daily tracking, expert-generated motivational messages, multiple reminders, summary score, compare to self
Behavioral: Charge
Text messaging-based study to determine effect of different components on weight loss.
Experimental: Arm 30: DT-EM-MR-SS-CG
Charge: daily tracking, expert-generated motivational messages, multiple reminders, summary score, compare to group
Behavioral: Charge
Text messaging-based study to determine effect of different components on weight loss.
Experimental: Arm 31: DT-EM-MR-GF-CS
Charge: daily tracking, expert-generated motivational messages, multiple reminders, specific goal feedback, compare to self
Behavioral: Charge
Text messaging-based study to determine effect of different components on weight loss.
Experimental: Arm 32: DT-EM-MR-GF-CG
Charge: daily tracking, expert-generated motivational messages, multiple reminders, specific goal feedback, compare to group.
Behavioral: Charge
Text messaging-based study to determine effect of different components on weight loss.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Average Weight Change
Time Frame: baseline, 6 months
Mean change in weight in kg (6 months post-randomization- baseline weight)
baseline, 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Diet
Time Frame: baseline, 6 months
To experimentally determine the effects of text messaging components and levels on change in dietary intake using The Rapid Eating Assessment for Participants - Shortened version (REAP-S). The range of score is 13 to 39, where a higher score indicates more healthy dietary intake.
baseline, 6 months
Average Change in Physical Activity
Time Frame: baseline, 6 months
To experimentally determine the effects of text messaging components and levels on change in weekly minutes of physical activity based on the WHO Global Physical Activity Questionnaire version 2 (GPAC 2). The range of scores is 0 minutes/week to 10,080 minutes/week (maximum number of minutes in a week).
baseline, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gary G Bennett, PhD, Bishop-MacDermott Family Professor of Psychology, Global Health & Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 31, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 29, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 12, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 21, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D0752

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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