Obesity
Conditions
Keywords
Weight Loss, Weight Maintenance
Brief summary
The investigators propose to conduct a randomized controlled trial assessing the impact of phone-based extended care delivered on an ADAPTIVE (when participants are at high risk for weight regain as assessed by a predictive algorithm) vs. STATIC (gold-standard, once-per-month frequency) schedule on weight loss maintenance. The study team will provide participants with an initial behavioral weight management program, and then randomize participants who successfully achieve a clinically-significant weight loss of ≥5% to one of the two extended-care conditions
Detailed description
Obesity remains a substantial public health challenge in the United States. While behavioral lifestyle interventions have been demonstrated to produce weight losses of 8-10% in adults with overweight and obesity, long-term outcomes are suboptimal, limiting effectiveness for long-term weight loss maintenance. The study team will evaluate methods for providing phone-based extended-care to support weight loss maintenance. The investigators propose to conduct a randomized controlled trial assessing the impact of phone-based extended care delivered on an ADAPTIVE (when we determine that participants are at high risk for weight regain) vs. STATIC (once-per-month frequency used in gold-standard extended-care programs) schedule on weight loss maintenance. Participants will be provided with an initial in-person, group-based behavioral weight management program. Participants who successfully achieve a clinically-significant weight loss between baseline and Month 4 (defined by the Institute of Medicine as a reduction in weight of ≥ 5% from baseline) will be randomized into the clinical trial. Follow-up visits will occur at Month 12 and Month 24 after initial intervention baseline.
Interventions
BEHAVIORALADAPTIVE Extended-Care Program
Each extended-care intervention phone call will be initiated by the interventionist, and will begin with a brief check-in followed by a discussion of any barriers experienced by participants in meeting their weight maintenance goals. Each call will end with a formal goal setting session. Calls are expected to last for approximately 10-20 minutes.
BEHAVIORALSTATIC Extended-Care Program
Each extended-care intervention phone call will be initiated by the interventionist, and will begin with a brief check-in followed by a discussion of any barriers experienced by participants in meeting their weight maintenance goals. Each call will end with a formal goal setting session. Calls are expected to last for approximately 10-20 minutes.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Assessments will be conducted by trained study staff members masked to maintenance condition.
Intervention model description
All randomized participants will receive extended-care intervention delivered via phone; however, the frequency/timing of these calls will vary between the ADAPTIVE and STATIC conditions.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* BMI 30.0-45.0 kg/m2 * Own a smartphone \[Apple iPhone (5s or newer) or Android smartphone (KitKat OS 4.4 or newer)\] with a cellular and data plan * Weight ≤ 396 pounds (due to scale limit) * Lose ≥ 5% of baseline weight during the initial weight loss intervention (Month 0 to Month 4) * Completion of baseline assessment measures
Exclusion criteria
* History of bariatric surgery * Current use of weight loss medications * Weight loss of ≥ 10 lb in prior 6 months * Physical limitations that prevent walking ¼ mile without stopping * Use of a pacemaker * Currently pregnant * Currently breastfeeding * Less than 1 year post-partum * Plans to become pregnant within the study period * Lack of written approval for participation from potential participant's physician if the participant has been diagnosed with type 2 diabetes, hypertension, or has a history of coronary heart disease * More than one participant per household (enrollment limited to one participant per household) * Medical conditions that contraindicate weight loss or prevent completion of the study (e.g., current diagnosis of cancer or terminal illness, dementia, or plans to relocate during the study period)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Weight Change Month 4 to Month 24 of the ADAPTIVE Group Compared to the STATIC Group, Controlling for Initial Weight Loss | Baseline; Month 4; Month 12; Month 24 | Participant body weight will be measured at baseline, Month 4, Month 12, and Month 24 using study-provided BodyTrace e-scales. Participants will be asked to measure their weight first thing in the morning on a scheduled assessment day, before having anything to eat or drink but after using the restroom, in no more than light indoor clothing and with pockets emptied and shoes removed. Analyses will examine difference in weight change from Month 4 to 24 by group, controlling for initial weight loss (i.e., weight change from baseline to Month 4). Thus, although the outcome (weight) is assessed at each time point, the primary outcome is only a single comparison. Weight in kg at each time point are reported below (using intent-to-treat analyses, with multiple imputation used to handle missing data) along with the difference in weight change from Month 4 to Month 24 by group (Month 24 weight - Month 4 weight), controlling for initial weight loss (Month 4 weight - Baseline weight). |
Countries
United States
Participant flow
Pre-assignment details
Adults with obesity were first offered a 16-week weight loss program; only participants who lost at least 5% of their baseline weight were eligible for randomization into the maintenance trial.
Participants by arm
| Arm | Count |
|---|---|
| ADAPTIVE Extended-Care Group Participants randomized to the ADAPTIVE extended-care program will receive extended-care intervention phone delivered only if either 1) an algorithm developed by our study team detects that a participant is at high risk for weight regain or 2) the participant self-initiates a request for a session. | 128 |
| STATIC Extended-Care Group Participants randomized to the STATIC extended-care program will receive the extended-care intervention phone calls on a fixed, once-per-month schedule (the schedule currently used in gold-standard weight maintenance programs). | 127 |
| Total | 255 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 3 |
| Overall Study | Began Anti-Obesity Medication | 3 | 3 |
| Overall Study | Began Other Weight Loss program | 4 | 8 |
| Overall Study | Incarceration | 0 | 1 |
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | Pregnancy | 1 | 1 |
| Overall Study | Protocol Violation | 0 | 1 |
Baseline characteristics
| Characteristic | STATIC Extended-Care Group | Total | ADAPTIVE Extended-Care Group |
|---|---|---|---|
| Age, Continuous | 50.4 years STANDARD_DEVIATION 12.1 | 50.6 years STANDARD_DEVIATION 11.3 | 50.8 years STANDARD_DEVIATION 10.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 25 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 115 Participants | 230 Participants | 115 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Initial Weight Loss Program Weight Change | -9.6 % change STANDARD_DEVIATION 3.4 | -9.5 % change STANDARD_DEVIATION 3.3 | -9.4 % change STANDARD_DEVIATION 3.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 4 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 28 Participants | 47 Participants | 19 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 9 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) White | 87 Participants | 190 Participants | 103 Participants |
| Sex: Female, Male Female | 99 Participants | 209 Participants | 110 Participants |
| Sex: Female, Male Male | 28 Participants | 46 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 128 | 1 / 127 |
| other Total, other adverse events | 50 / 128 | 33 / 127 |
| serious Total, serious adverse events | 10 / 128 | 16 / 127 |
Outcome results
Primary
Difference in Weight Change Month 4 to Month 24 of the ADAPTIVE Group Compared to the STATIC Group, Controlling for Initial Weight Loss
Participant body weight will be measured at baseline, Month 4, Month 12, and Month 24 using study-provided BodyTrace e-scales. Participants will be asked to measure their weight first thing in the morning on a scheduled assessment day, before having anything to eat or drink but after using the restroom, in no more than light indoor clothing and with pockets emptied and shoes removed. Analyses will examine difference in weight change from Month 4 to 24 by group, controlling for initial weight loss (i.e., weight change from baseline to Month 4). Thus, although the outcome (weight) is assessed at each time point, the primary outcome is only a single comparison. Weight in kg at each time point are reported below (using intent-to-treat analyses, with multiple imputation used to handle missing data) along with the difference in weight change from Month 4 to Month 24 by group (Month 24 weight - Month 4 weight), controlling for initial weight loss (Month 4 weight - Baseline weight).
Time frame: Baseline; Month 4; Month 12; Month 24
Population: These numbers differ from numbers reported under participant flow as we conducted intent-to-treat analyses, using all available data from all participant and multiple imputation used to handle missing data (see statistical analysis plan)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| ADAPTIVE Extended-Care Group | Difference in Weight Change Month 4 to Month 24 of the ADAPTIVE Group Compared to the STATIC Group, Controlling for Initial Weight Loss | Month 4 | 90.18 Weight (kg) |
| ADAPTIVE Extended-Care Group | Difference in Weight Change Month 4 to Month 24 of the ADAPTIVE Group Compared to the STATIC Group, Controlling for Initial Weight Loss | Month 24 | 91.45 Weight (kg) |
| ADAPTIVE Extended-Care Group | Difference in Weight Change Month 4 to Month 24 of the ADAPTIVE Group Compared to the STATIC Group, Controlling for Initial Weight Loss | Month 12 | 89.18 Weight (kg) |
| ADAPTIVE Extended-Care Group | Difference in Weight Change Month 4 to Month 24 of the ADAPTIVE Group Compared to the STATIC Group, Controlling for Initial Weight Loss | Primary Outcome (weight change from Month 4 to 24, controlling for initial weight loss) | 1.27 Weight (kg) |
| ADAPTIVE Extended-Care Group | Difference in Weight Change Month 4 to Month 24 of the ADAPTIVE Group Compared to the STATIC Group, Controlling for Initial Weight Loss | Baseline | 99.57 Weight (kg) |
| STATIC Extended-Care Group | Difference in Weight Change Month 4 to Month 24 of the ADAPTIVE Group Compared to the STATIC Group, Controlling for Initial Weight Loss | Primary Outcome (weight change from Month 4 to 24, controlling for initial weight loss) | 1.75 Weight (kg) |
| STATIC Extended-Care Group | Difference in Weight Change Month 4 to Month 24 of the ADAPTIVE Group Compared to the STATIC Group, Controlling for Initial Weight Loss | Baseline | 100.22 Weight (kg) |
| STATIC Extended-Care Group | Difference in Weight Change Month 4 to Month 24 of the ADAPTIVE Group Compared to the STATIC Group, Controlling for Initial Weight Loss | Month 4 | 90.59 Weight (kg) |
| STATIC Extended-Care Group | Difference in Weight Change Month 4 to Month 24 of the ADAPTIVE Group Compared to the STATIC Group, Controlling for Initial Weight Loss | Month 12 | 90.15 Weight (kg) |
| STATIC Extended-Care Group | Difference in Weight Change Month 4 to Month 24 of the ADAPTIVE Group Compared to the STATIC Group, Controlling for Initial Weight Loss | Month 24 | 92.34 Weight (kg) |