Trial Outcomes & Findings for Maintenance After Initiation of Nutrition TrAINing (NCT NCT01357551)

NCT ID: NCT01357551

Last Updated: 2016-11-02

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 222 participants
• Primary outcome timeframe: 56 weeks post-randomization
• Results posted on: 2016-11-02

Participant Flow

573 people were consented. Of those, 69 did not return to provide a weight at study entry. Of the 504 who provided a weight at study entry, 200 dropped out, 82 lost < 4 kg, and 222 lost at least 4 kg and thus were eligible for randomization in the maintenance phase.

Participant milestones

Measure	Maintenance Intervention Participants receive theoretically-informed maintenance intervention for 42 weeks, followed by 16 weeks of no intervention contact to examine sustainability. Interventions: Theoretically-informed maintenance intervention that involves in-person group visits that transition to individualized telephone calls, and the frequency of contact with the interventionist gradually decreases over time.	Usual Care Participants receive usual care for 56 weeks
Overall Study STARTED	110	112
Overall Study COMPLETED	88	101
Overall Study NOT COMPLETED	22	11

Reasons for withdrawal

Measure	Maintenance Intervention Participants receive theoretically-informed maintenance intervention for 42 weeks, followed by 16 weeks of no intervention contact to examine sustainability. Interventions: Theoretically-informed maintenance intervention that involves in-person group visits that transition to individualized telephone calls, and the frequency of contact with the interventionist gradually decreases over time.	Usual Care Participants receive usual care for 56 weeks
Overall Study Withdrawal by Subject	6	4
Overall Study Death	0	1
Overall Study Lost to Follow-up	16	6

Baseline Characteristics

Maintenance After Initiation of Nutrition TrAINing

Baseline characteristics by cohort

Measure	Maintenance Intervention n=110 Participants Participants are randomized to a theoretically-informed maintenance intervention for 42 weeks, followed by 14 weeks of no intervention contact to examine sustainability. The maintenance intervention will involve in-person group visits that transition to individualized telephone calls, and the frequency of contact with the interventionist will gradually taper over time. Interventions: Theoretically-informed maintenance intervention that involves in-person group visits that transition to individualized telephone calls, and the frequency of contact with the interventionist will gradually taper over time.	Usual Care n=112 Participants Participants are randomized to receive usual care for 56 weeks	Total n=222 Participants Total of all reporting groups
Age, Continuous	61.5 years STANDARD_DEVIATION 8.3 • n=5 Participants	62.0 years STANDARD_DEVIATION 8.3 • n=7 Participants	61.8 years STANDARD_DEVIATION 8.3 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	17 Participants n=7 Participants	34 Participants n=5 Participants
Sex: Female, Male Male	93 Participants n=5 Participants	95 Participants n=7 Participants	188 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	105 Participants n=5 Participants	111 Participants n=7 Participants	216 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	38 Participants n=5 Participants	45 Participants n=7 Participants	83 Participants n=5 Participants
Race (NIH/OMB) White	67 Participants n=5 Participants	62 Participants n=7 Participants	129 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	110 participants n=5 Participants	112 participants n=7 Participants	222 participants n=5 Participants
Weight loss during initiation phase	7.2 kilograms STANDARD_DEVIATION 2.8 • n=5 Participants	7.2 kilograms STANDARD_DEVIATION 3.4 • n=7 Participants	7.2 kilograms STANDARD_DEVIATION 3.1 • n=5 Participants
Weight	102.1 kilograms STANDARD_DEVIATION 19.8 • n=5 Participants	105.0 kilograms STANDARD_DEVIATION 21.0 • n=7 Participants	103.6 kilograms STANDARD_DEVIATION 20.4 • n=5 Participants
Body mass index	33.3 kilograms per meter squared STANDARD_DEVIATION 5.7 • n=5 Participants	34.6 kilograms per meter squared STANDARD_DEVIATION 6.4 • n=7 Participants	34.0 kilograms per meter squared STANDARD_DEVIATION 6.1 • n=5 Participants
Education high school graduate	106 participants n=5 Participants	111 participants n=7 Participants	217 participants n=5 Participants
Education not high school graduate	3 participants n=5 Participants	1 participants n=7 Participants	4 participants n=5 Participants
Education missing	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Current tobacco user yes	5 participants n=5 Participants	9 participants n=7 Participants	14 participants n=5 Participants
Current tobacco user no	105 participants n=5 Participants	102 participants n=7 Participants	207 participants n=5 Participants
Current tobacco user missing	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Employment status working full time or part-time	33 participants n=5 Participants	28 participants n=7 Participants	61 participants n=5 Participants
Employment status retired	59 participants n=5 Participants	65 participants n=7 Participants	124 participants n=5 Participants
Employment status other/disabled	17 participants n=5 Participants	18 participants n=7 Participants	35 participants n=5 Participants
Employment status missing	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 56 weeks post-randomization

Outcome measures

Measure	Maintenance Intervention n=110 Participants Participants are randomized to a theoretically-informed maintenance intervention for 42 weeks, followed by 16 weeks of no intervention contact to examine sustainability. The maintenance intervention will involve in-person group visits that transition to individualized telephone calls, and the frequency of contact with the interventionist will gradually taper over time. Interventions: Theoretically-informed maintenance intervention that involves in-person group visits that transition to individualized telephone calls, and the frequency of contact with the interventionist will gradually taper over time.	Usual Care n=112 Participants Participants are randomized to receive usual care for 56 weeks
Weight	99.2 kilograms Standard Deviation 17.7	105.7 kilograms Standard Deviation 20.1

SECONDARY outcome

Timeframe: 56 weeks

Based on self-report using Block Brief Food Frequency Questionnaire

Outcome measures

Measure	Maintenance Intervention n=110 Participants Participants are randomized to a theoretically-informed maintenance intervention for 42 weeks, followed by 16 weeks of no intervention contact to examine sustainability. The maintenance intervention will involve in-person group visits that transition to individualized telephone calls, and the frequency of contact with the interventionist will gradually taper over time. Interventions: Theoretically-informed maintenance intervention that involves in-person group visits that transition to individualized telephone calls, and the frequency of contact with the interventionist will gradually taper over time.	Usual Care n=112 Participants Participants are randomized to receive usual care for 56 weeks
Estimated Daily Caloric Intake	1207.5 kcal per day Standard Deviation 548.3	1339.1 kcal per day Standard Deviation 750.5

SECONDARY outcome

Timeframe: 56 weeks

self-reported based on short form of International Physical Activity Questionnaire

Outcome measures

Measure	Maintenance Intervention n=110 Participants Participants are randomized to a theoretically-informed maintenance intervention for 42 weeks, followed by 16 weeks of no intervention contact to examine sustainability. The maintenance intervention will involve in-person group visits that transition to individualized telephone calls, and the frequency of contact with the interventionist will gradually taper over time. Interventions: Theoretically-informed maintenance intervention that involves in-person group visits that transition to individualized telephone calls, and the frequency of contact with the interventionist will gradually taper over time.	Usual Care n=112 Participants Participants are randomized to receive usual care for 56 weeks
Estimated Metabolic Minutes of Walking Per Week	680.72 metabolic minutes per week Standard Deviation 721.23	665.43 metabolic minutes per week Standard Deviation 822.30

SECONDARY outcome

Timeframe: 56 weeks

self-reported based on short form of International Physical Activity Questionnaire

Outcome measures

Measure	Maintenance Intervention n=110 Participants Participants are randomized to a theoretically-informed maintenance intervention for 42 weeks, followed by 16 weeks of no intervention contact to examine sustainability. The maintenance intervention will involve in-person group visits that transition to individualized telephone calls, and the frequency of contact with the interventionist will gradually taper over time. Interventions: Theoretically-informed maintenance intervention that involves in-person group visits that transition to individualized telephone calls, and the frequency of contact with the interventionist will gradually taper over time.	Usual Care n=112 Participants Participants are randomized to receive usual care for 56 weeks
Estimated Metabolic Minutes of Moderate Physical Activity Per Week	783.40 metabolic minutes per week Standard Deviation 1175.57	810.25 metabolic minutes per week Standard Deviation 1215.14

Adverse Events

Maintenance Intervention

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Maintenance Intervention n=110 participants at risk Participants receive a theoretically-informed maintenance intervention for 42 weeks, followed by 16 weeks of no intervention contact to examine sustainability. The maintenance intervention involves in-person group visits that transition to individualized telephone calls, and the frequency of contact gradually decreases over time. Maintenance intervention: Theoretically-informed maintenance intervention that involves in-person group visits that transition to individualized telephone calls, and the frequency of contact gradually decreases over time.	Usual Care n=112 participants at risk Participants receive usual care for 56 weeks
Cardiac disorders Emergency room visit due to high blood pressure	0.91% 1/110 • Number of events 1 • 56-week study period	0.00% 0/112 • 56-week study period
General disorders Death	0.91% 1/110 • Number of events 1 • 56-week study period	0.89% 1/112 • Number of events 1 • 56-week study period
Musculoskeletal and connective tissue disorders emergency room visit due to knee pain	0.91% 1/110 • Number of events 1 • 56-week study period	0.00% 0/112 • 56-week study period
Psychiatric disorders Emergency room visit due to anxiety	0.91% 1/110 • Number of events 1 • 56-week study period	0.00% 0/112 • 56-week study period

Other adverse events

Adverse event data not reported

Additional Information

Dr. Corrine Voils

Durham VA Medical Center

Phone: 9192860411

Email: corrine.voils@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place