Obesity, Weight Loss
Conditions
Keywords
text message, digital health, weight loss, personalized
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.
Interventions
BEHAVIORALCharge
Text messaging-based study to determine effect of different components on weight loss.
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Weight Change | baseline, 6 months | Mean change in weight in kg (6 months post-randomization- baseline weight) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Diet | 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. |
| Average Change in Physical Activity | 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). |
Countries
United States
Participant flow
Pre-assignment details
Those who were eligible and consented to be in the study, prior to randomization.
Participants by arm
| Arm | Count |
|---|---|
| Experimental: Arm 1: WT-SM-OR-SS-CS Charge: weekly tracking, self-generated motivational messages, one reminder, summary score, compare to self | 17 |
| Experimental: Arm 2: WT-SM-OR-SS-CG Charge: weekly tracking, self-generated motivational messages, one reminder, summary score, compare to group | 16 |
| Experimental: Arm 3: WT-SM-OR-SF-CS Charge: weekly tracking, self-generated motivational messages, one reminder, specific goal feedback, compare to self | 17 |
| Experimental: Arm 4: WT-SM-OR-SF-CG Charge: weekly tracking, self-generated motivational messages, one reminder, specific goal feedback, compare to group | 17 |
| Experimental: Arm 5: WT-SM-MR-SS-CS Charge: weekly tracking, self-generated motivational messages, multiple reminders, summary score, compare to self. | 16 |
| Experimental: Arm 6: WT-SM-MR-SS-CG Charge: weekly tracking, self-generated motivational messages, multiple reminders, summary score, compare to group. | 15 |
| Experimental: Arm 7: WT-SM-MR-SF-CS Charge: weekly tracking, self-generated motivational messages, multiple reminders, specific feedback, compare to self | 17 |
| Experimental: Arm 8: WT-SM-MR-SF-CG Charge: weekly tracking, self-generated motivational messages, multiple reminders, specific feedback, compare to group | 17 |
| Experimental: Arm 9: WT-EM-OR-SS-CS Charge: weekly tracking, expert-generated motivational messages, one reminder, summary score, compare to self | 18 |
| Experimental: Arm 10: WT-EM-OR-SS-CG Charge: weekly tracking, expert-generated motivational messages, one reminder, summary score, compare to group | 17 |
| Experimental: Arm 11: WT-EM-OR-SF-CS Charge: weekly tracking, expert-generated motivational messages, one reminder, specific goal feedback, compare to self | 18 |
| Experimental: Arm 12: WT-EM-OR-SF-CG Charge: weekly tracking, expert-generated motivational messages, one reminder, specific goal feedback, compare to group. | 16 |
| Experimental: Arm 13: WT-EM-MR-SS-CS Charge: weekly tracking, expert-generated motivational messages, multiple reminders, summary score, compare to self | 16 |
| Experimental: Arm 14: WT-EM-MR-SS-CG Charge: weekly tracking, expert-generated motivational messages, multiple reminders,summary score, compare to group | 15 |
| Experimental: Arm 15: WT-EM-MR-SF-CS Charge: weekly tracking, expert-generated motivational messages, multiple reminders, specific goal feedback, compare to self | 18 |
| Experimental: Arm 16: WT-EM-MR-SF-CG Charge: weekly tracking, expert-generated motivational messages, multiple reminders, specific goal feedback, compare to group | 16 |
| Experimental: Arm 17: DT-SM-OR-SS-CS Charge: daily tracking, self-generated motivational messages, one reminder, summary score, compare to self. | 18 |
| Experimental: Arm 18: DT-SM-OR-SS-CG Charge: daily tracking, self-generated motivational messages, one reminder, summary score, compare to group | 16 |
| Experimental: Arm 19: DT-SM-OR-SF-CS Charge: daily tracking, self-generated motivational messages, one reminder, specific goal feedback, compare to self. | 15 |
| Experimental: Arm 20: DT-SM-OR-SF-CG Charge: daily tracking, self-generated motivational messages, one reminder, specific goal feedback, compare to group | 17 |
| Experimental: Arm 21: DT-SM-MR-SS-CS Charge: daily tracking, self-generated motivational messages, multiple reminders, summary score, compare to self | 18 |
| Experimental: Arm 22: DT-SM-MR-SS-CG Charge: daily tracking, self-generated motivational messages, multiple reminders, summary score, compare to group. | 16 |
| Experimental: Arm 23: DT-SM-MR-SF-CS Charge: daily tracking, self-generated motivational messages, multiple reminders, specific goal feedback, compare to self. | 15 |
| Experimental: Arm 24: DT-SM-MR-SF-CG Charge: daily tracking, self-generated motivational messages, multiple reminders, specific goal feedback, compare to group | 17 |
| Experimental: Arm 25: DT-EM-OR-SS-CS Charge: daily tracking, expert-generated motivational messages, one reminder, summary score, compare to self | 18 |
| Experimental: Arm 26: DT-EM-OR-SS-CG Charge: daily tracking, expert-generated motivational messages, one reminder, summary score, compare to group | 17 |
| Experimental: Arm 27: DT-EM-OR-SF-CS Charge: daily tracking, expert-generated motivational messages, one reminder, specific goal feedback, compare to self | 17 |
| Experimental: Arm 28: DT-EM-OR-SF-CG Charge: daily tracking, expert-generated motivational messages, one reminder, specific goal feedback, compare to group | 17 |
| Experimental: Arm 29: DT-EM-MR-SS-CS Charge: daily tracking, expert-generated motivational messages, multiple reminders, summary score, compare to self | 16 |
| Experimental: Arm 30: DT-EM-MR-SS-CG Charge: daily tracking, expert-generated motivational messages, multiple reminders, summary score, compare to group | 15 |
| Experimental: Arm 31: DT-EM-MR-GF-CS Charge: daily tracking, expert-generated motivational messages, multiple reminders, specific goal feedback, compare to self | 19 |
| Experimental: Arm 32: DT-EM-MR-GF-CG Charge: daily tracking, expert-generated motivational messages, multiple reminders, specific goal feedback, compare to group. | 17 |
| Total | 534 |
Baseline characteristics
| Characteristic | Experimental: Arm 4: WT-SM-OR-SF-CG | Experimental: Arm 31: DT-EM-MR-GF-CS | Experimental: Arm 6: WT-SM-MR-SS-CG | Experimental: Arm 21: DT-SM-MR-SS-CS | Experimental: Arm 32: DT-EM-MR-GF-CG | Experimental: Arm 5: WT-SM-MR-SS-CS | Experimental: Arm 25: DT-EM-OR-SS-CS | Experimental: Arm 20: DT-SM-OR-SF-CG | Experimental: Arm 19: DT-SM-OR-SF-CS | Experimental: Arm 23: DT-SM-MR-SF-CS | Experimental: Arm 2: WT-SM-OR-SS-CG | Experimental: Arm 18: DT-SM-OR-SS-CG | Experimental: Arm 26: DT-EM-OR-SS-CG | Experimental: Arm 17: DT-SM-OR-SS-CS | Experimental: Arm 24: DT-SM-MR-SF-CG | Experimental: Arm 16: WT-EM-MR-SF-CG | Experimental: Arm 27: DT-EM-OR-SF-CS | Experimental: Arm 15: WT-EM-MR-SF-CS | Experimental: Arm 14: WT-EM-MR-SS-CG | Experimental: Arm 28: DT-EM-OR-SF-CG | Experimental: Arm 13: WT-EM-MR-SS-CS | Total | Experimental: Arm 12: WT-EM-OR-SF-CG | Experimental: Arm 11: WT-EM-OR-SF-CS | Experimental: Arm 29: DT-EM-MR-SS-CS | Experimental: Arm 10: WT-EM-OR-SS-CG | Experimental: Arm 3: WT-SM-OR-SF-CS | Experimental: Arm 22: DT-SM-MR-SS-CG | Experimental: Arm 9: WT-EM-OR-SS-CS | Experimental: Arm 8: WT-SM-MR-SF-CG | Experimental: Arm 1: WT-SM-OR-SS-CS | Experimental: Arm 30: DT-EM-MR-SS-CG | Experimental: Arm 7: WT-SM-MR-SF-CS |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 4 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 19 Participants | 15 Participants | 18 Participants | 16 Participants | 16 Participants | 18 Participants | 17 Participants | 15 Participants | 14 Participants | 16 Participants | 16 Participants | 16 Participants | 18 Participants | 17 Participants | 16 Participants | 17 Participants | 17 Participants | 15 Participants | 17 Participants | 16 Participants | 530 Participants | 16 Participants | 18 Participants | 16 Participants | 17 Participants | 17 Participants | 16 Participants | 18 Participants | 17 Participants | 17 Participants | 15 Participants | 17 Participants |
| Age, Continuous | 44.4 years STANDARD_DEVIATION 12.6 | 32.0 years STANDARD_DEVIATION 4.8 | 46.5 years STANDARD_DEVIATION 11.8 | 42.6 years STANDARD_DEVIATION 12.4 | 34.6 years STANDARD_DEVIATION 7.8 | 39.4 years STANDARD_DEVIATION 10.5 | 33.4 years STANDARD_DEVIATION 5.5 | 41.2 years STANDARD_DEVIATION 11.7 | 42.0 years STANDARD_DEVIATION 10.9 | 43.2 years STANDARD_DEVIATION 14 | 39.5 years STANDARD_DEVIATION 12.3 | 44.9 years STANDARD_DEVIATION 12.4 | 36.3 years STANDARD_DEVIATION 6.4 | 42.6 years STANDARD_DEVIATION 13.2 | 34.4 years STANDARD_DEVIATION 5.4 | 40.6 years STANDARD_DEVIATION 11.6 | 33.4 years STANDARD_DEVIATION 6.2 | 41.2 years STANDARD_DEVIATION 13.3 | 45.2 years STANDARD_DEVIATION 12.9 | 32.5 years STANDARD_DEVIATION 6.1 | 45.4 years STANDARD_DEVIATION 13.7 | 33.9 years STANDARD_DEVIATION 6.1 | 41.0 years STANDARD_DEVIATION 11.6 | 42.8 years STANDARD_DEVIATION 13.9 | 36.6 years STANDARD_DEVIATION 7.1 | 43.0 years STANDARD_DEVIATION 12.8 | 46.8 years STANDARD_DEVIATION 10.7 | 37.9 years STANDARD_DEVIATION 7.8 | 37.2 years STANDARD_DEVIATION 8.7 | 41.2 years STANDARD_DEVIATION 11.8 | 35.8 years STANDARD_DEVIATION 8.3 | 34.3 years STANDARD_DEVIATION 3.7 | 40.2 years STANDARD_DEVIATION 14.9 |
| BMI | 32.7 kg/m^2 STANDARD_DEVIATION 6.2 | 32.0 kg/m^2 STANDARD_DEVIATION 4.8 | 33.9 kg/m^2 STANDARD_DEVIATION 7.2 | 33.6 kg/m^2 STANDARD_DEVIATION 5.5 | 34.6 kg/m^2 STANDARD_DEVIATION 7.7 | 34.9 kg/m^2 STANDARD_DEVIATION 7.2 | 33.4 kg/m^2 STANDARD_DEVIATION 5.5 | 32.8 kg/m^2 STANDARD_DEVIATION 4.6 | 32.9 kg/m^2 STANDARD_DEVIATION 5.6 | 33.9 kg/m^2 STANDARD_DEVIATION 6.6 | 33.2 kg/m^2 STANDARD_DEVIATION 5.9 | 34.9 kg/m^2 STANDARD_DEVIATION 6.1 | 36.3 kg/m^2 STANDARD_DEVIATION 6.4 | 32.1 kg/m^2 STANDARD_DEVIATION 4.6 | 34.4 kg/m^2 STANDARD_DEVIATION 5.4 | 32.8 kg/m^2 STANDARD_DEVIATION 4.9 | 33.4 kg/m^2 STANDARD_DEVIATION 6.2 | 36.7 kg/m^2 STANDARD_DEVIATION 6.4 | 32.5 kg/m^2 STANDARD_DEVIATION 5.7 | 32.5 kg/m^2 STANDARD_DEVIATION 6.1 | 35.8 kg/m^2 STANDARD_DEVIATION 5.4 | 33.9 kg/m^2 STANDARD_DEVIATION 6.1 | 33.7 kg/m^2 STANDARD_DEVIATION 4.4 | 34.4 kg/m^2 STANDARD_DEVIATION 7.2 | 36.6 kg/m^2 STANDARD_DEVIATION 7.1 | 32.1 kg/m^2 STANDARD_DEVIATION 5.2 | 30.6 kg/m^2 STANDARD_DEVIATION 2.8 | 36.2 kg/m^2 STANDARD_DEVIATION 7.9 | 36.9 kg/m^2 STANDARD_DEVIATION 8.3 | 35.9 kg/m^2 STANDARD_DEVIATION 7.3 | 34.1 kg/m^2 STANDARD_DEVIATION 6 | 34.3 kg/m^2 STANDARD_DEVIATION 3.7 | 32.4 kg/m^2 STANDARD_DEVIATION 7.5 |
| Personal income $25,000 through $49,999 | 4 Participants | 6 Participants | 6 Participants | 4 Participants | 5 Participants | 7 Participants | 4 Participants | 2 Participants | 1 Participants | 5 Participants | 6 Participants | 5 Participants | 2 Participants | 5 Participants | 2 Participants | 3 Participants | 2 Participants | 3 Participants | 5 Participants | 4 Participants | 5 Participants | 135 Participants | 4 Participants | 6 Participants | 8 Participants | 6 Participants | 4 Participants | 2 Participants | 8 Participants | 3 Participants | 2 Participants | 3 Participants | 3 Participants |
| Personal income $50,000 and greater | 10 Participants | 10 Participants | 7 Participants | 10 Participants | 10 Participants | 5 Participants | 9 Participants | 11 Participants | 10 Participants | 8 Participants | 7 Participants | 9 Participants | 10 Participants | 10 Participants | 8 Participants | 9 Participants | 7 Participants | 9 Participants | 6 Participants | 12 Participants | 6 Participants | 279 Participants | 7 Participants | 11 Participants | 7 Participants | 10 Participants | 11 Participants | 12 Participants | 4 Participants | 10 Participants | 9 Participants | 7 Participants | 8 Participants |
| Personal income Less than $25,000 | 1 Participants | 3 Participants | 2 Participants | 3 Participants | 2 Participants | 4 Participants | 4 Participants | 3 Participants | 1 Participants | 1 Participants | 2 Participants | 2 Participants | 3 Participants | 3 Participants | 7 Participants | 4 Participants | 8 Participants | 5 Participants | 4 Participants | 0 Participants | 3 Participants | 100 Participants | 4 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants | 2 Participants | 5 Participants | 4 Participants | 6 Participants | 4 Participants | 6 Participants |
| Personal income Missing | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 3 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 2 Participants | 20 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic (all races) | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 3 Participants | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 3 Participants | 1 Participants | 1 Participants | 2 Participants | 3 Participants | 1 Participants | 1 Participants | 2 Participants | 36 Participants | 3 Participants | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 2 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Non-Hispanic Black | 4 Participants | 1 Participants | 4 Participants | 3 Participants | 3 Participants | 3 Participants | 0 Participants | 3 Participants | 3 Participants | 5 Participants | 0 Participants | 1 Participants | 2 Participants | 1 Participants | 2 Participants | 4 Participants | 1 Participants | 3 Participants | 3 Participants | 2 Participants | 2 Participants | 77 Participants | 2 Participants | 2 Participants | 4 Participants | 4 Participants | 2 Participants | 3 Participants | 5 Participants | 2 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Non-Hispanic Other | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 3 Participants | 2 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 30 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 3 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Non-Hispanic White | 12 Participants | 18 Participants | 10 Participants | 13 Participants | 13 Participants | 10 Participants | 13 Participants | 10 Participants | 11 Participants | 10 Participants | 14 Participants | 15 Participants | 14 Participants | 13 Participants | 14 Participants | 11 Participants | 12 Participants | 11 Participants | 10 Participants | 13 Participants | 12 Participants | 391 Participants | 11 Participants | 15 Participants | 9 Participants | 11 Participants | 15 Participants | 12 Participants | 11 Participants | 13 Participants | 11 Participants | 14 Participants | 10 Participants |
| Region of Enrollment United States | 17 participants | 19 participants | 15 participants | 18 participants | 17 participants | 16 participants | 18 participants | 17 participants | 15 participants | 15 participants | 16 participants | 16 participants | 17 participants | 18 participants | 17 participants | 16 participants | 17 participants | 18 participants | 15 participants | 17 participants | 16 participants | 534 participants | 16 participants | 18 participants | 16 participants | 17 participants | 17 participants | 16 participants | 18 participants | 17 participants | 17 participants | 15 participants | 17 participants |
| Sex/Gender, Customized Gender - Self Described Female | 13 Participants | 13 Participants | 11 Participants | 12 Participants | 12 Participants | 12 Participants | 13 Participants | 13 Participants | 11 Participants | 11 Participants | 11 Participants | 12 Participants | 13 Participants | 13 Participants | 13 Participants | 12 Participants | 12 Participants | 12 Participants | 11 Participants | 12 Participants | 12 Participants | 386 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 13 Participants | 11 Participants | 13 Participants | 12 Participants | 12 Participants | 11 Participants | 12 Participants |
| Sex/Gender, Customized Gender - Self Described Male | 4 Participants | 5 Participants | 4 Participants | 5 Participants | 5 Participants | 4 Participants | 5 Participants | 4 Participants | 4 Participants | 4 Participants | 5 Participants | 4 Participants | 4 Participants | 5 Participants | 4 Participants | 4 Participants | 5 Participants | 6 Participants | 4 Participants | 5 Participants | 4 Participants | 145 Participants | 4 Participants | 5 Participants | 4 Participants | 5 Participants | 4 Participants | 5 Participants | 5 Participants | 5 Participants | 5 Participants | 4 Participants | 5 Participants |
| Sex/Gender, Customized Gender - Self Described Other (self described as genderqueer or nonbinary) | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk | EG018 affected / at risk | EG019 affected / at risk | EG020 affected / at risk | EG021 affected / at risk | EG022 affected / at risk | EG023 affected / at risk | EG024 affected / at risk | EG025 affected / at risk | EG026 affected / at risk | EG027 affected / at risk | EG028 affected / at risk | EG029 affected / at risk | EG030 affected / at risk | EG031 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 16 | 0 / 17 | 0 / 17 | 0 / 16 | 0 / 15 | 0 / 17 | 0 / 17 | 0 / 18 | 0 / 17 | 0 / 18 | 0 / 16 | 0 / 16 | 0 / 15 | 0 / 18 | 0 / 16 | 0 / 18 | 0 / 16 | 0 / 15 | 0 / 17 | 0 / 18 | 0 / 16 | 0 / 15 | 0 / 17 | 0 / 18 | 0 / 17 | 0 / 17 | 0 / 17 | 0 / 16 | 0 / 15 | 0 / 19 | 0 / 17 |
| other Total, other adverse events | 0 / 17 | 0 / 16 | 0 / 17 | 0 / 17 | 0 / 16 | 0 / 15 | 0 / 17 | 0 / 17 | 0 / 18 | 0 / 17 | 0 / 18 | 0 / 16 | 0 / 16 | 0 / 15 | 1 / 18 | 0 / 16 | 0 / 18 | 0 / 16 | 0 / 15 | 0 / 17 | 0 / 18 | 0 / 16 | 0 / 15 | 0 / 17 | 0 / 18 | 0 / 17 | 0 / 17 | 0 / 17 | 0 / 16 | 0 / 15 | 0 / 19 | 0 / 17 |
| serious Total, serious adverse events | 0 / 17 | 0 / 16 | 0 / 17 | 0 / 17 | 0 / 16 | 0 / 15 | 0 / 17 | 0 / 17 | 0 / 18 | 0 / 17 | 0 / 18 | 0 / 16 | 0 / 16 | 0 / 15 | 0 / 18 | 0 / 16 | 0 / 18 | 0 / 16 | 0 / 15 | 0 / 17 | 0 / 18 | 0 / 16 | 0 / 15 | 0 / 17 | 0 / 18 | 0 / 17 | 0 / 17 | 0 / 17 | 0 / 16 | 0 / 15 | 0 / 19 | 0 / 17 |
Outcome results
Primary
Average Weight Change
Mean change in weight in kg (6 months post-randomization- baseline weight)
Time frame: baseline, 6 months
Population: The primary outcome was 6-month change in weight (kg), measured at each in-person visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Arm 1: WT-SM-OR-SS-CS | Average Weight Change | 0.1 Weight in kg | Standard Deviation 3.3 |
| Experimental: Arm 2: WT-SM-OR-SS-CG | Average Weight Change | -0.4 Weight in kg | Standard Deviation 2.7 |
| Experimental: Arm 3: WT-SM-OR-SF-CS | Average Weight Change | -3.4 Weight in kg | Standard Deviation 4.3 |
| Experimental: Arm 4: WT-SM-OR-SF-CG | Average Weight Change | -0.8 Weight in kg | Standard Deviation 4.8 |
| Experimental: Arm 5: WT-SM-MR-SS-CS | Average Weight Change | -3.3 Weight in kg | Standard Deviation 8.1 |
| Experimental: Arm 6: WT-SM-MR-SS-CG | Average Weight Change | -1.3 Weight in kg | Standard Deviation 5.8 |
| Experimental: Arm 7: WT-SM-MR-SF-CS | Average Weight Change | -0.9 Weight in kg | Standard Deviation 5.6 |
| Experimental: Arm 8: WT-SM-MR-SF-CG | Average Weight Change | -2.3 Weight in kg | Standard Deviation 5.6 |
| Experimental: Arm 9: WT-EM-OR-SS-CS | Average Weight Change | -2.9 Weight in kg | Standard Deviation 3.8 |
| Experimental: Arm 10: WT-EM-OR-SS-CG | Average Weight Change | -0.7 Weight in kg | Standard Deviation 2.3 |
| Experimental: Arm 11: WT-EM-OR-SF-CS | Average Weight Change | -1.0 Weight in kg | Standard Deviation 3.6 |
| Experimental: Arm 12: WT-EM-OR-SF-CG | Average Weight Change | -3.0 Weight in kg | Standard Deviation 5.8 |
| Experimental: Arm 13: WT-EM-MR-SS-CS | Average Weight Change | -2.9 Weight in kg | Standard Deviation 6.5 |
| Experimental: Arm 14: WT-EM-MR-SS-CG | Average Weight Change | -1.5 Weight in kg | Standard Deviation 2.3 |
| Experimental: Arm 15: WT-EM-MR-SF-CS | Average Weight Change | -2.1 Weight in kg | Standard Deviation 7.2 |
| Experimental: Arm 16: WT-EM-MR-SF-CG | Average Weight Change | -2.5 Weight in kg | Standard Deviation 2.8 |
| Experimental: Arm 17: DT-SM-OR-SS-CS | Average Weight Change | -3.1 Weight in kg | Standard Deviation 4.3 |
| Experimental: Arm 18: DT-SM-OR-SS-CG | Average Weight Change | -4.5 Weight in kg | Standard Deviation 5.9 |
| Experimental: Arm 19: DT-SM-OR-SF-CS | Average Weight Change | -2.8 Weight in kg | Standard Deviation 2.7 |
| Experimental: Arm 20: DT-SM-OR-SF-CG | Average Weight Change | -1.9 Weight in kg | Standard Deviation 4.6 |
| Experimental: Arm 21: DT-SM-MR-SS-CS | Average Weight Change | -1.5 Weight in kg | Standard Deviation 3 |
| Experimental: Arm 22: DT-SM-MR-SS-CG | Average Weight Change | -0.3 Weight in kg | Standard Deviation 4.1 |
| Experimental: Arm 23: DT-SM-MR-SF-CS | Average Weight Change | -0.5 Weight in kg | Standard Deviation 2.2 |
| Experimental: Arm 24: DT-SM-MR-SF-CG | Average Weight Change | -1.0 Weight in kg | Standard Deviation 5.9 |
| Experimental: Arm 25: DT-EM-OR-SS-CS | Average Weight Change | -2.7 Weight in kg | Standard Deviation 6.3 |
| Experimental: Arm 26: DT-EM-OR-SS-CG | Average Weight Change | -3.3 Weight in kg | Standard Deviation 6.2 |
| Experimental: Arm 27: DT-EM-OR-SF-CS | Average Weight Change | -2.4 Weight in kg | Standard Deviation 5.5 |
| Experimental: Arm 28: DT-EM-OR-SF-CG | Average Weight Change | -1.8 Weight in kg | Standard Deviation 3.3 |
| Experimental: Arm 29: DT-EM-MR-SS-CS | Average Weight Change | -3.5 Weight in kg | Standard Deviation 6.2 |
| Experimental: Arm 30: DT-EM-MR-SS-CG | Average Weight Change | -2.8 Weight in kg | Standard Deviation 6.4 |
| Experimental: Arm 31: DT-EM-MR-GF-CS | Average Weight Change | 0.2 Weight in kg | Standard Deviation 3.6 |
| Experimental: Arm 32: DT-EM-MR-GF-CG | Average Weight Change | -1.0 Weight in kg | Standard Deviation 6.5 |
Secondary
Average Change in Physical Activity
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).
Time frame: baseline, 6 months
Population: Average difference of GPAC 2 scores at 6 months as compared to baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Arm 1: WT-SM-OR-SS-CS | Average Change in Physical Activity | 202.2 minutes per week | Standard Deviation 718.6 |
| Experimental: Arm 2: WT-SM-OR-SS-CG | Average Change in Physical Activity | 103.8 minutes per week | Standard Deviation 208.5 |
| Experimental: Arm 3: WT-SM-OR-SF-CS | Average Change in Physical Activity | 256.8 minutes per week | Standard Deviation 762 |
| Experimental: Arm 4: WT-SM-OR-SF-CG | Average Change in Physical Activity | 335.6 minutes per week | Standard Deviation 449.9 |
| Experimental: Arm 5: WT-SM-MR-SS-CS | Average Change in Physical Activity | 88.6 minutes per week | Standard Deviation 138.2 |
| Experimental: Arm 6: WT-SM-MR-SS-CG | Average Change in Physical Activity | 241.5 minutes per week | Standard Deviation 684.8 |
| Experimental: Arm 7: WT-SM-MR-SF-CS | Average Change in Physical Activity | 390.6 minutes per week | Standard Deviation 859 |
| Experimental: Arm 8: WT-SM-MR-SF-CG | Average Change in Physical Activity | 202.9 minutes per week | Standard Deviation 385.5 |
| Experimental: Arm 9: WT-EM-OR-SS-CS | Average Change in Physical Activity | 106.9 minutes per week | Standard Deviation 285.8 |
| Experimental: Arm 10: WT-EM-OR-SS-CG | Average Change in Physical Activity | 159.2 minutes per week | Standard Deviation 381.2 |
| Experimental: Arm 11: WT-EM-OR-SF-CS | Average Change in Physical Activity | 143.1 minutes per week | Standard Deviation 413.5 |
| Experimental: Arm 12: WT-EM-OR-SF-CG | Average Change in Physical Activity | 319.1 minutes per week | Standard Deviation 620.3 |
| Experimental: Arm 13: WT-EM-MR-SS-CS | Average Change in Physical Activity | 81.2 minutes per week | Standard Deviation 754.5 |
| Experimental: Arm 14: WT-EM-MR-SS-CG | Average Change in Physical Activity | 390.0 minutes per week | Standard Deviation 732.4 |
| Experimental: Arm 15: WT-EM-MR-SF-CS | Average Change in Physical Activity | 41.1 minutes per week | Standard Deviation 208.1 |
| Experimental: Arm 16: WT-EM-MR-SF-CG | Average Change in Physical Activity | -26.4 minutes per week | Standard Deviation 274.2 |
| Experimental: Arm 17: DT-SM-OR-SS-CS | Average Change in Physical Activity | -76.5 minutes per week | Standard Deviation 382.6 |
| Experimental: Arm 18: DT-SM-OR-SS-CG | Average Change in Physical Activity | 70.0 minutes per week | Standard Deviation 548.8 |
| Experimental: Arm 19: DT-SM-OR-SF-CS | Average Change in Physical Activity | 48.2 minutes per week | Standard Deviation 264 |
| Experimental: Arm 20: DT-SM-OR-SF-CG | Average Change in Physical Activity | -362.7 minutes per week | Standard Deviation 2225.4 |
| Experimental: Arm 21: DT-SM-MR-SS-CS | Average Change in Physical Activity | 45.0 minutes per week | Standard Deviation 154.1 |
| Experimental: Arm 22: DT-SM-MR-SS-CG | Average Change in Physical Activity | 75.0 minutes per week | Standard Deviation 171.6 |
| Experimental: Arm 23: DT-SM-MR-SF-CS | Average Change in Physical Activity | -54.4 minutes per week | Standard Deviation 525.8 |
| Experimental: Arm 24: DT-SM-MR-SF-CG | Average Change in Physical Activity | 95.9 minutes per week | Standard Deviation 325.8 |
| Experimental: Arm 25: DT-EM-OR-SS-CS | Average Change in Physical Activity | 197.7 minutes per week | Standard Deviation 401.9 |
| Experimental: Arm 26: DT-EM-OR-SS-CG | Average Change in Physical Activity | 201.3 minutes per week | Standard Deviation 646.4 |
| Experimental: Arm 27: DT-EM-OR-SF-CS | Average Change in Physical Activity | 105.8 minutes per week | Standard Deviation 419.4 |
| Experimental: Arm 28: DT-EM-OR-SF-CG | Average Change in Physical Activity | -21.3 minutes per week | Standard Deviation 418.1 |
| Experimental: Arm 29: DT-EM-MR-SS-CS | Average Change in Physical Activity | -76.9 minutes per week | Standard Deviation 272.2 |
| Experimental: Arm 30: DT-EM-MR-SS-CG | Average Change in Physical Activity | 408.2 minutes per week | Standard Deviation 652 |
| Experimental: Arm 31: DT-EM-MR-GF-CS | Average Change in Physical Activity | 505.5 minutes per week | Standard Deviation 1167.1 |
| Experimental: Arm 32: DT-EM-MR-GF-CG | Average Change in Physical Activity | 48.6 minutes per week | Standard Deviation 302.4 |
Secondary
Change in Diet
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.
Time frame: baseline, 6 months
Population: Average change in REAP-S score (6-months - baseline).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Arm 1: WT-SM-OR-SS-CS | Change in Diet | 0.8 score on a scale | Standard Deviation 4 |
| Experimental: Arm 2: WT-SM-OR-SS-CG | Change in Diet | 2 score on a scale | Standard Deviation 5 |
| Experimental: Arm 3: WT-SM-OR-SF-CS | Change in Diet | 4.4 score on a scale | Standard Deviation 3.1 |
| Experimental: Arm 4: WT-SM-OR-SF-CG | Change in Diet | 1.2 score on a scale | Standard Deviation 3.8 |
| Experimental: Arm 5: WT-SM-MR-SS-CS | Change in Diet | 3.8 score on a scale | Standard Deviation 5.8 |
| Experimental: Arm 6: WT-SM-MR-SS-CG | Change in Diet | 2.6 score on a scale | Standard Deviation 3.4 |
| Experimental: Arm 7: WT-SM-MR-SF-CS | Change in Diet | 1.8 score on a scale | Standard Deviation 3.5 |
| Experimental: Arm 8: WT-SM-MR-SF-CG | Change in Diet | 1.8 score on a scale | Standard Deviation 3.9 |
| Experimental: Arm 9: WT-EM-OR-SS-CS | Change in Diet | 1.8 score on a scale | Standard Deviation 3.5 |
| Experimental: Arm 10: WT-EM-OR-SS-CG | Change in Diet | 2 score on a scale | Standard Deviation 2.9 |
| Experimental: Arm 11: WT-EM-OR-SF-CS | Change in Diet | 2.4 score on a scale | Standard Deviation 3.2 |
| Experimental: Arm 12: WT-EM-OR-SF-CG | Change in Diet | 2.2 score on a scale | Standard Deviation 3.6 |
| Experimental: Arm 13: WT-EM-MR-SS-CS | Change in Diet | 2.7 score on a scale | Standard Deviation 3.3 |
| Experimental: Arm 14: WT-EM-MR-SS-CG | Change in Diet | 2.9 score on a scale | Standard Deviation 2.7 |
| Experimental: Arm 15: WT-EM-MR-SF-CS | Change in Diet | 3.3 score on a scale | Standard Deviation 4.7 |
| Experimental: Arm 16: WT-EM-MR-SF-CG | Change in Diet | 1.5 score on a scale | Standard Deviation 2.3 |
| Experimental: Arm 17: DT-SM-OR-SS-CS | Change in Diet | 2.4 score on a scale | Standard Deviation 3.1 |
| Experimental: Arm 18: DT-SM-OR-SS-CG | Change in Diet | 3.7 score on a scale | Standard Deviation 4.8 |
| Experimental: Arm 19: DT-SM-OR-SF-CS | Change in Diet | 1.4 score on a scale | Standard Deviation 2.5 |
| Experimental: Arm 20: DT-SM-OR-SF-CG | Change in Diet | 0.4 score on a scale | Standard Deviation 3.2 |
| Experimental: Arm 21: DT-SM-MR-SS-CS | Change in Diet | 2.8 score on a scale | Standard Deviation 3.6 |
| Experimental: Arm 22: DT-SM-MR-SS-CG | Change in Diet | 1.1 score on a scale | Standard Deviation 4.6 |
| Experimental: Arm 23: DT-SM-MR-SF-CS | Change in Diet | 2.5 score on a scale | Standard Deviation 2.9 |
| Experimental: Arm 24: DT-SM-MR-SF-CG | Change in Diet | 1.5 score on a scale | Standard Deviation 2.5 |
| Experimental: Arm 25: DT-EM-OR-SS-CS | Change in Diet | 1.1 score on a scale | Standard Deviation 4.6 |
| Experimental: Arm 26: DT-EM-OR-SS-CG | Change in Diet | 3.8 score on a scale | Standard Deviation 3.1 |
| Experimental: Arm 27: DT-EM-OR-SF-CS | Change in Diet | 2.9 score on a scale | Standard Deviation 4.1 |
| Experimental: Arm 28: DT-EM-OR-SF-CG | Change in Diet | 1.2 score on a scale | Standard Deviation 3.4 |
| Experimental: Arm 29: DT-EM-MR-SS-CS | Change in Diet | 1.9 score on a scale | Standard Deviation 2.5 |
| Experimental: Arm 30: DT-EM-MR-SS-CG | Change in Diet | 1.6 score on a scale | Standard Deviation 2.7 |
| Experimental: Arm 31: DT-EM-MR-GF-CS | Change in Diet | 0.9 score on a scale | Standard Deviation 4 |
| Experimental: Arm 32: DT-EM-MR-GF-CG | Change in Diet | 3.7 score on a scale | Standard Deviation 4.7 |