Overweight and Obesity
Conditions
Brief summary
The goal of this pilot trial is to pilot test an intervention to help prevent weight gain or produce weight loss among adults with obesity. Participants are asked to self-weigh on a smart scale for one year. Feasibility and acceptability outcomes are examined.
Detailed description
To prevent weight gain while overcoming these common barriers to engaging in weight management interventions, we propose an intervention that prescribes self-weighing but does not prescribe changes in diet or physical activity behaviors or require attendance at didactic-focused meetings. The potential of self-weighing to promote weight management is supported both by self-regulatory theory and empirical research. Promoting self-weighing may activate participants' self-regulatory skills, leading to spontaneous decisions to reduce calorie intake or increase physical activity, thus preventing further weight gain. The proposed intervention will also provide individuals with text message-based feedback to promote continued self-weighing and to motivate engagement with evidence-based resources for weight management at a time when they may be more open to using these resources-e.g., after experiencing a small weight gain. The current proposal will investigate the feasibility and acceptability of this low burden self-weighing intervention in order to prepare for a fully-powered, pragmatic randomized controlled trial. We will enroll 40 patients with either obesity or overweight with a weight-related comorbidity and who have declined to participate in a comprehensive behavioral weight management program. Participants will be asked to weigh themselves daily via a smart scale that transmits weight data directly to the study team via the cellular network. Every-other week, participants will be sent text messages providing brief feedback encouraging continued self-weighing. Moreover, if a small weight gain is observed, participants will be sent text messages aiming to engage them in commercial or community-based evidence-based weight management resources. In a single-arm design, all enrolled participants will receive the intervention for 12 months and will complete assessments at 3 and 12 months to assess feasibility and acceptability of the intervention and trial design, while weight will be obtained from participants' Electronic Health Records (EHR). We will evaluate our success in meeting pre-specified metrics for trial feasibility and intervention acceptability outcomes, including intervention enrollment, intervention satisfaction, and obtainment of weight data abstracted from participants' EHRs. We will also evaluate the success of the intervention in promoting regular self-weighing and use of evidence-based weight management resources.
Interventions
BEHAVIORALSteady Intervention
Participants will be asked to weigh themselves daily via a smart scale that transmits weight data directly to the study team via the cellular network for 12 months. Every-other week, participants will be sent text messages providing brief feedback encouraging continued self-weighing. Moreover, if a small weight gain is observed, participants will be sent text messages aiming to engage them in commercial or community-based evidence-based weight management resources.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Florida
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Single-arm trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-70 * Body weight recorded in EHR in the prior month from a primary care setting. * Last BMI in EHR either ≥30 kg/m2 or between 25.0-29.9 kg/m2 with documented weight-related comorbidity (hypertension, type II diabetes, pre-diabetes, dyslipidemia, sleep apnea). * Weight ≤ 375 lbs. * Self-report sending and receiving at least one text message per month for past 6 months. * Not currently enrolled in comprehensive behavioral weight loss treatment. * Respond no to question asking if they would like to enroll in a comprehensive weight loss program in the next month * Has not engaged in self-weighing ≥ 5 times per week on average over prior month. * Not pregnant, breastfeeding, or planning to become pregnant in next 6 months. * Not currently undergoing radiation or chemotherapy for cancer. * No history of eating disorders. * Interested in enrolling in low-burden self-weighing intervention. * Able to read and understand English without help
Exclusion criteria
* History of Congestive Heart Failure or heart attack in past 6 months. * Planning to move out of the region in the following 12 months * Answer incorrectly on an attention check/ validation survey item
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention Satisfaction | 12 months. | (NOTE: this is a pilot study and there is not a true primary outcome. There are several descriptive outcomes that will inform our decision to proceed to a traditional, fully powered clincial trial). Intervention satisfaction reported here is response to item overall, I am satisfied with this program. with response options 1-5, 1-strongly disagree, 3-neither agree nor disagree, and 5-strongly agree. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Engagement in Self Weighing, First Quarter | months 0-3 | days/week in which weight was registered |
| Engagement in Self Weighing, Final Quarter | months 9-12 | mean days per week in which weight was registered |
| Retention in Study | 12 months | Percent of participants completing 12 month survey. (There is no measurement used for this. It is based on the portion of patients who complete the 12 month survey.) |
| Representatives of Those Who Enroll | At recruitment | Percent of those participants who enroll who are male. |
| Use of Evidence-based Resources Offered | 12 months | Percent of patients who initiate use of comprehensive weight loss program |
| Percent of Patients Who Enroll | at recruitment | Percent of those who are eligible who are interested in and enroll in the Steady Intervention out of those who complete the screening measure. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Steady Intervention Enrollees Participants who enrolled in the Steady Intervention | 39 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Steady Intervention Enrollees |
|---|---|
| Age, Continuous | 44.7 years STANDARD_DEVIATION 13.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 34 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 24 Participants |
| Region of Enrollment United States | 39 participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 39 |
| other Total, other adverse events | 0 / 39 |
| serious Total, serious adverse events | 0 / 39 |
Outcome results
Primary
Intervention Satisfaction
(NOTE: this is a pilot study and there is not a true primary outcome. There are several descriptive outcomes that will inform our decision to proceed to a traditional, fully powered clincial trial). Intervention satisfaction reported here is response to item overall, I am satisfied with this program. with response options 1-5, 1-strongly disagree, 3-neither agree nor disagree, and 5-strongly agree.
Time frame: 12 months.
Population: Those who completed 12 month assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Steady Intervention Enrollees | Intervention Satisfaction | 4.1 score on a scale | Standard Deviation 1 |
Secondary
Engagement in Self Weighing, Final Quarter
mean days per week in which weight was registered
Time frame: months 9-12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Steady Intervention Enrollees | Engagement in Self Weighing, Final Quarter | 4.2 days/week | Standard Deviation 1.7 |
Secondary
Engagement in Self Weighing, First Quarter
days/week in which weight was registered
Time frame: months 0-3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Steady Intervention Enrollees | Engagement in Self Weighing, First Quarter | 4.9 days/week | Standard Deviation 1.2 |
Secondary
Percent of Patients Who Enroll
Percent of those who are eligible who are interested in and enroll in the Steady Intervention out of those who complete the screening measure.
Time frame: at recruitment
Population: those who were offered steady
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Steady Intervention Enrollees | Percent of Patients Who Enroll | 39 Participants |
Secondary
Representatives of Those Who Enroll
Percent of those participants who enroll who are male.
Time frame: At recruitment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Steady Intervention Enrollees | Representatives of Those Who Enroll | 20 Participants |
Secondary
Retention in Study
Percent of participants completing 12 month survey. (There is no measurement used for this. It is based on the portion of patients who complete the 12 month survey.)
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Steady Intervention Enrollees | Retention in Study | 34 Participants |
Secondary
Use of Evidence-based Resources Offered
Percent of patients who initiate use of comprehensive weight loss program
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Steady Intervention Enrollees | Use of Evidence-based Resources Offered | 3 Participants |