Trial Outcomes & Findings for Support and Tracking to Achieve Results (Project STAR) (NCT NCT04116853)

Last Updated: 2025-11-05

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

255 participants

Primary outcome timeframe

Baseline; Month 4; Month 12; Month 24

Results posted on

2025-11-05

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.	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).
Overall Study STARTED	128	127
Overall Study Month 12	126	120
Overall Study COMPLETED	117	110
Overall Study NOT COMPLETED	11	17

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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).
Overall Study Adverse Event	1	3
Overall Study Lost to Follow-up	2	0
Overall Study Incarceration	0	1
Overall Study Pregnancy	1	1
Overall Study Began Other Weight Loss program	4	8
Overall Study Began Anti-Obesity Medication	3	3
Overall Study Protocol Violation	0	1

Baseline Characteristics

Support and Tracking to Achieve Results (Project STAR)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ADAPTIVE Extended-Care Group n=128 Participants 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.	STATIC Extended-Care Group n=127 Participants 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).	Total n=255 Participants Total of all reporting groups
Race (NIH/OMB) More than one race	4 Participants n=15 Participants	5 Participants n=161 Participants	9 Participants n=100 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=15 Participants	2 Participants n=161 Participants	3 Participants n=100 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=15 Participants	12 Participants n=161 Participants	25 Participants n=100 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	115 Participants n=15 Participants	115 Participants n=161 Participants	230 Participants n=100 Participants
Age, Continuous	50.8 years STANDARD_DEVIATION 10.5 • n=15 Participants	50.4 years STANDARD_DEVIATION 12.1 • n=161 Participants	50.6 years STANDARD_DEVIATION 11.3 • n=100 Participants
Sex: Female, Male Female	110 Participants n=15 Participants	99 Participants n=161 Participants	209 Participants n=100 Participants
Sex: Female, Male Male	18 Participants n=15 Participants	28 Participants n=161 Participants	46 Participants n=100 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=15 Participants	1 Participants n=161 Participants	2 Participants n=100 Participants
Race (NIH/OMB) Asian	0 Participants n=15 Participants	4 Participants n=161 Participants	4 Participants n=100 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=15 Participants	0 Participants n=161 Participants	0 Participants n=100 Participants
Race (NIH/OMB) Black or African American	19 Participants n=15 Participants	28 Participants n=161 Participants	47 Participants n=100 Participants
Race (NIH/OMB) White	103 Participants n=15 Participants	87 Participants n=161 Participants	190 Participants n=100 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=15 Participants	0 Participants n=161 Participants	0 Participants n=100 Participants
Initial Weight Loss Program Weight Change	-9.4 % change STANDARD_DEVIATION 3.3 • n=15 Participants	-9.6 % change STANDARD_DEVIATION 3.4 • n=161 Participants	-9.5 % change STANDARD_DEVIATION 3.3 • n=100 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	ADAPTIVE Extended-Care Group n=128 Participants 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.	STATIC Extended-Care Group n=127 Participants 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).
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) Interval 97.12 to 102.02	100.22 Weight (kg) Interval 97.46 to 102.98
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) Interval 87.88 to 92.48	90.59 Weight (kg) Interval 87.85 to 93.33
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) Interval 86.73 to 91.63	90.15 Weight (kg) Interval 87.1 to 93.2
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) Interval 88.87 to 94.03	92.34 Weight (kg) Interval 89.26 to 95.42
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) Interval 0.07 to 2.47	1.75 Weight (kg) Interval 0.43 to 3.06

Adverse Events

ADAPTIVE Extended-Care Group

Serious events: 10 serious events

Other events: 50 other events

Deaths: 0 deaths

STATIC Extended-Care Group

Serious events: 16 serious events

Other events: 33 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	ADAPTIVE Extended-Care Group n=128 participants at risk 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.	STATIC Extended-Care Group n=127 participants at risk 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).
Infections and infestations COVID-19	13.3% 17/128 • Number of events 17 • From enrollment until the end of the study (Month 24)	7.1% 9/127 • Number of events 9 • From enrollment until the end of the study (Month 24)
Infections and infestations Sinusitis	4.7% 6/128 • Number of events 6 • From enrollment until the end of the study (Month 24)	5.5% 7/127 • Number of events 7 • From enrollment until the end of the study (Month 24)
Injury, poisoning and procedural complications Trip/Fall	7.8% 10/128 • Number of events 10 • From enrollment until the end of the study (Month 24)	5.5% 7/127 • Number of events 9 • From enrollment until the end of the study (Month 24)
Musculoskeletal and connective tissue disorders Back pain	5.5% 7/128 • Number of events 8 • From enrollment until the end of the study (Month 24)	6.3% 8/127 • Number of events 9 • From enrollment until the end of the study (Month 24)
Surgical and medical procedures Tooth extraction	7.8% 10/128 • Number of events 10 • From enrollment until the end of the study (Month 24)	1.6% 2/127 • Number of events 2 • From enrollment until the end of the study (Month 24)

Additional Information

Kathryn Ross, PhD MPH

Advocate Aurora Research Institute

Phone: 414-647-6312

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	ADAPTIVE Extended-Care Group n=128 participants at risk 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.	STATIC Extended-Care Group n=127 participants at risk 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).
Infections and infestations Lung infection	0.78% 1/128 • Number of events 1 • From enrollment until the end of the study (Month 24)	0.00% 0/127 • From enrollment until the end of the study (Month 24)
Injury, poisoning and procedural complications Nerve damage in arm and neck after car accident	0.78% 1/128 • Number of events 1 • From enrollment until the end of the study (Month 24)	0.00% 0/127 • From enrollment until the end of the study (Month 24)
Investigations Headaches and tinnitus	0.78% 1/128 • Number of events 1 • From enrollment until the end of the study (Month 24)	0.00% 0/127 • From enrollment until the end of the study (Month 24)
Musculoskeletal and connective tissue disorders Muscle weakness	0.00% 0/128 • From enrollment until the end of the study (Month 24)	0.79% 1/127 • Number of events 1 • From enrollment until the end of the study (Month 24)
Nervous system disorders Seizure after car accident	0.00% 0/128 • From enrollment until the end of the study (Month 24)	0.79% 1/127 • Number of events 1 • From enrollment until the end of the study (Month 24)
Nervous system disorders Syncope	0.00% 0/128 • From enrollment until the end of the study (Month 24)	0.79% 1/127 • Number of events 1 • From enrollment until the end of the study (Month 24)
Nervous system disorders Myasthenia gravis	0.00% 0/128 • From enrollment until the end of the study (Month 24)	0.79% 1/127 • Number of events 1 • From enrollment until the end of the study (Month 24)
Nervous system disorders Transient ischemic attacks	0.78% 1/128 • Number of events 1 • From enrollment until the end of the study (Month 24)	0.00% 0/127 • From enrollment until the end of the study (Month 24)
Psychiatric disorders Mania	0.78% 1/128 • Number of events 1 • From enrollment until the end of the study (Month 24)	0.00% 0/127 • From enrollment until the end of the study (Month 24)
Surgical and medical procedures Gallbladder removal	0.78% 1/128 • Number of events 1 • From enrollment until the end of the study (Month 24)	1.6% 2/127 • Number of events 2 • From enrollment until the end of the study (Month 24)
Surgical and medical procedures Hysterectomy	0.00% 0/128 • From enrollment until the end of the study (Month 24)	0.79% 1/127 • Number of events 1 • From enrollment until the end of the study (Month 24)
Surgical and medical procedures Hernia surgery	0.00% 0/128 • From enrollment until the end of the study (Month 24)	0.79% 1/127 • Number of events 1 • From enrollment until the end of the study (Month 24)
Surgical and medical procedures Shoulder replacement surgery	0.78% 1/128 • Number of events 1 • From enrollment until the end of the study (Month 24)	0.00% 0/127 • From enrollment until the end of the study (Month 24)
Surgical and medical procedures Heart bypass surgery	0.00% 0/128 • From enrollment until the end of the study (Month 24)	0.79% 1/127 • Number of events 1 • From enrollment until the end of the study (Month 24)
Surgical and medical procedures C5 and C6 vertebrae surgery	0.00% 0/128 • From enrollment until the end of the study (Month 24)	0.79% 1/127 • Number of events 1 • From enrollment until the end of the study (Month 24)
Surgical and medical procedures Neurosurgery for Chiari malformation	0.00% 0/128 • From enrollment until the end of the study (Month 24)	0.79% 1/127 • Number of events 1 • From enrollment until the end of the study (Month 24)
Surgical and medical procedures Laparoscopic cholecystectomy	0.78% 1/128 • Number of events 1 • From enrollment until the end of the study (Month 24)	0.00% 0/127 • From enrollment until the end of the study (Month 24)
Blood and lymphatic system disorders Autoimmune hemolytic anemia	0.00% 0/128 • From enrollment until the end of the study (Month 24)	0.79% 1/127 • Number of events 1 • From enrollment until the end of the study (Month 24)
Cardiac disorders Atrial fibrillation	0.00% 0/128 • From enrollment until the end of the study (Month 24)	0.79% 1/127 • Number of events 1 • From enrollment until the end of the study (Month 24)
Cardiac disorders Heart failure	0.78% 1/128 • Number of events 1 • From enrollment until the end of the study (Month 24)	0.00% 0/127 • From enrollment until the end of the study (Month 24)
Gastrointestinal disorders Pancreatitis	0.78% 1/128 • Number of events 1 • From enrollment until the end of the study (Month 24)	0.00% 0/127 • From enrollment until the end of the study (Month 24)
Gastrointestinal disorders Diverticulitis	0.00% 0/128 • From enrollment until the end of the study (Month 24)	0.79% 1/127 • Number of events 1 • From enrollment until the end of the study (Month 24)
Gastrointestinal disorders Dehydration	0.00% 0/128 • From enrollment until the end of the study (Month 24)	1.6% 2/127 • Number of events 2 • From enrollment until the end of the study (Month 24)