Trial Outcomes & Findings for Intervention to Promote Weight Loss in Latinas At-risk for Diabetes (NCT NCT02088034)
NCT ID: NCT02088034
Last Updated: 2020-12-22
Results Overview
Study tests difference in body weight (Weight in kg) between treatment conditions and usual care at 12 months.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
92 participants
Primary outcome timeframe
1 year
Results posted on
2020-12-22
Participant Flow
Participant milestones
| Measure |
Promotora-led Intervention
The PLI consists of a core curriculum or 12 group sessions of 90 minute duration over a 12-week period and will be followed by a maintenance phase of 10 biweekly and then monthly 90-minute sessions during months 4 through 12. One promotora will lead each session in Spanish, exploring such topics as being active, low-fat diets, portion control, self monitoring, problem solving and life-style changes.
Prometra led intervention: Behavioral life-style program lead by a team of trained community health workers (called promotoras) with 2 principal goals - encouraging participants to lose 7% of their total weight and complete 150 minutes of moderate physical activity per week.
|
Usual Care
One physician visit at Puentes de Salud or Congreso Health Center to discuss healthy lifestyle behaviors that promote weight loss and diabetes prevention. During that visit, UC participants will also receive standard educational materials in Spanish from the NIDDK Weight-control Information Network covering the same topics. UC participants will receive another physician visit upon completion of 1-year follow-up to review laboratory assessments.
Usual Care: Participants in this arm will attend one physician visit to discuss healthy lifestyle behaviors and will receive standard educational materials.
|
Metformin Therapy
Participants randomized to the metformin arm of the study will receive this medication from months 1 through 12 after randomization. Subjects will receive 850 mg daily for 1 month and increase to 850 mg twice daily thereafter if no side effects are experienced.
Metformin Therapy: Participants in this group will receive metformin 850 mg bid for one year.
|
|---|---|---|---|
|
Overall Study
STARTED
|
33
|
30
|
29
|
|
Overall Study
COMPLETED
|
30
|
28
|
27
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
2
|
Reasons for withdrawal
| Measure |
Promotora-led Intervention
The PLI consists of a core curriculum or 12 group sessions of 90 minute duration over a 12-week period and will be followed by a maintenance phase of 10 biweekly and then monthly 90-minute sessions during months 4 through 12. One promotora will lead each session in Spanish, exploring such topics as being active, low-fat diets, portion control, self monitoring, problem solving and life-style changes.
Prometra led intervention: Behavioral life-style program lead by a team of trained community health workers (called promotoras) with 2 principal goals - encouraging participants to lose 7% of their total weight and complete 150 minutes of moderate physical activity per week.
|
Usual Care
One physician visit at Puentes de Salud or Congreso Health Center to discuss healthy lifestyle behaviors that promote weight loss and diabetes prevention. During that visit, UC participants will also receive standard educational materials in Spanish from the NIDDK Weight-control Information Network covering the same topics. UC participants will receive another physician visit upon completion of 1-year follow-up to review laboratory assessments.
Usual Care: Participants in this arm will attend one physician visit to discuss healthy lifestyle behaviors and will receive standard educational materials.
|
Metformin Therapy
Participants randomized to the metformin arm of the study will receive this medication from months 1 through 12 after randomization. Subjects will receive 850 mg daily for 1 month and increase to 850 mg twice daily thereafter if no side effects are experienced.
Metformin Therapy: Participants in this group will receive metformin 850 mg bid for one year.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
|
Overall Study
Pregnancy
|
2
|
1
|
2
|
Baseline Characteristics
Intervention to Promote Weight Loss in Latinas At-risk for Diabetes
Baseline characteristics by cohort
| Measure |
Promotora-led Intervention
n=33 Participants
The PLI consists of a core curriculum or 12 group sessions of 90 minute duration over a 12-week period and will be followed by a maintenance phase of 10 biweekly and then monthly 90-minute sessions during months 4 through 12. One promotora will lead each session in Spanish, exploring such topics as being active, low-fat diets, portion control, self monitoring, problem solving and life-style changes.
Prometra led intervention: Behavioral life-style program lead by a team of trained community health workers (called promotoras) with 2 principal goals - encouraging participants to lose 7% of their total weight and complete 150 minutes of moderate physical activity per week.
|
Usual Care
n=30 Participants
One physician visit at Puentes de Salud or Congreso Health Center to discuss healthy lifestyle behaviors that promote weight loss and diabetes prevention. During that visit, UC participants will also receive standard educational materials in Spanish from the NIDDK Weight-control Information Network covering the same topics. UC participants will receive another physician visit upon completion of 1-year follow-up to review laboratory assessments.
Usual Care: Participants in this arm will attend one physician visit to discuss healthy lifestyle behaviors and will receive standard educational materials.
|
Metformin Therapy
n=29 Participants
Participants randomized to the metformin arm of the study will receive this medication from months 1 through 12 after randomization. Subjects will receive 850 mg daily for 1 month and increase to 850 mg twice daily thereafter if no side effects are experienced.
Metformin Therapy: Participants in this group will receive metformin 850 mg bid for one year.
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
92 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Continuous
|
45.5 years
STANDARD_DEVIATION 12.3 • n=93 Participants
|
44 years
STANDARD_DEVIATION 13.6 • n=4 Participants
|
45.8 years
STANDARD_DEVIATION 11.7 • n=27 Participants
|
45.1 years
STANDARD_DEVIATION 12.5 • n=483 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
92 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=93 Participants
|
30 participants
n=4 Participants
|
29 participants
n=27 Participants
|
92 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 1 yearStudy tests difference in body weight (Weight in kg) between treatment conditions and usual care at 12 months.
Outcome measures
| Measure |
Promotora-led Intervention
n=30 Participants
The PLI consists of a core curriculum or 12 group sessions of 90 minute duration over a 12-week period and will be followed by a maintenance phase of 10 biweekly and then monthly 90-minute sessions during months 4 through 12. One promotora will lead each session in Spanish, exploring such topics as being active, low-fat diets, portion control, self monitoring, problem solving and life-style changes.
Prometra led intervention: Behavioral life-style program lead by a team of trained community health workers (called promotoras) with 2 principal goals - encouraging participants to lose 7% of their total weight and complete 150 minutes of moderate physical activity per week.
|
Usual Care
n=28 Participants
One physician visit at Puentes de Salud or Congreso Health Center to discuss healthy lifestyle behaviors that promote weight loss and diabetes prevention. During that visit, UC participants will also receive standard educational materials in Spanish from the NIDDK Weight-control Information Network covering the same topics. UC participants will receive another physician visit upon completion of 1-year follow-up to review laboratory assessments.
Usual Care: Participants in this arm will attend one physician visit to discuss healthy lifestyle behaviors and will receive standard educational materials.
|
Metformin Therapy
n=27 Participants
Participants randomized to the metformin arm of the study will receive this medication from months 1 through 12 after randomization. Subjects will receive 850 mg daily for 1 month and increase to 850 mg twice daily thereafter if no side effects are experienced.
Metformin Therapy: Participants in this group will receive metformin 850 mg bid for one year.
|
|---|---|---|---|
|
Body Weight
|
-4.0 kg
Interval -5.5 to -2.6
|
.8 kg
Interval -0.8 to 2.3
|
-.9 kg
Interval -2.4 to 0.6
|
Adverse Events
Promotora-led Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Metformin Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place