An interventional study of Maintenance intervention in Obesity, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 18 Years to 74 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-02.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
Obesity is the second leading cause of preventable deaths in the United States and is associated with a wide range of diseases. In people who are obese, weight loss improves blood pressure, dyslipidemia, glycemia, and arthritis symptoms; reduces medication use for several disease processes; increases physical functioning; and enhances health-related quality of life. The current study evaluated a theoretically informed maintenance intervention. If effective, this intervention could reduce the need for future clinic visits to treat obesity and its many associated illnesses.
Obesity is the second leading cause of preventable deaths in the United States and is associated with a wide range of diseases. In people who are obese, weight loss improves blood pressure, dyslipidemia, glycemia, and arthritis symptoms; reduces medication use for several disease processes; increases physical functioning; and enhances health-related quality of life. Despite these benefits, most patients who achieve weight loss regain much of this weight within a year, and few effective behavioral weight maintenance interventions have been identified. Thus, there is a dire need for effective interventions that can promote weight loss maintenance. Theoretical and empirical studies indicate that behavior maintenance is a distinct state that involves different psychological processes and behavioral skills than initial behavior change. The few trials that have tested weight loss maintenance interventions have not taken this distinction into account, which may partially explain their modest findings. The current study evaluated the efficacy of a theoretically informed maintenance intervention compared to usual care. If efficacious, this intervention could reduce the need for future clinic visits to treat obesity and its many associated illnesses and could serve as a model for redesigning the MOVE! program. This 3.5-year study involved a two-arm, randomized, controlled trial. During the run-in phase, Veterans with BMI 30 kg/m2 participated in a 4-month, intensive, group-based weight loss program. Participants who lost at least 4 kg by the end of 4 months (n=222) were randomized to receive (a) usual care (n=112) for 56 weeks or (b) a theoretically-informed maintenance intervention (n=110) for 42 weeks months, followed by 14 weeks of no intervention contact to examine sustainability. The maintenance intervention involved in-person group visits that transition to individualized telephone calls, and the frequency of contact with the interventionist gradually tapered over time. Outcomes were assessed at randomization and at weeks 14, 26, 42, and 56 post-randomization. The hypotheses are that the maintenance intervention will result in at least 3.5 kg greater weight loss and greater improvements in caloric intake and physical activity over the study period, and that it will be cost-effective, compared to usual care.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 222 is above the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants receive a theoretically-informed maintenance intervention for 42 weeks, followed by 14 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.
Behavioral: Maintenance intervention
Participants receive usual care for 56 weeks
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.
Weight
Time frame: 56 weeks post-randomization
Estimated Daily Caloric Intake
Based on self-report using Block Brief Food Frequency Questionnaire
Time frame: 56 weeks
Estimated Metabolic Minutes of Walking Per Week
self-reported based on short form of International Physical Activity Questionnaire
Time frame: 56 weeks
Estimated Metabolic Minutes of Moderate Physical Activity Per Week
self-reported based on short form of International Physical Activity Questionnaire
Time frame: 56 weeks
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.
| Milestone | Maintenance Intervention | Usual Care |
|---|---|---|
| Started | 110 | 112 |
| Completed | 88 | 101 |
| Not completed | 22 | 11 |
| Withdrew: Withdrawal by subject | 6 | 4 |
| Withdrew: Death | 0 | 1 |
| Withdrew: Lost to follow-up | 16 | 6 |
| kilograms | Maintenance Intervention | Usual Care |
|---|---|---|
| Weight | 99.2 ± 17.7 | 105.7 ± 20.1 |
Based on self-report using Block Brief Food Frequency Questionnaire
| kcal per day | Maintenance Intervention | Usual Care |
|---|---|---|
| Estimated Daily Caloric Intake | 1207.5 ± 548.3 | 1339.1 ± 750.5 |
self-reported based on short form of International Physical Activity Questionnaire
| metabolic minutes per week | Maintenance Intervention | Usual Care |
|---|---|---|
| Estimated Metabolic Minutes of Walking Per Week | 680.72 ± 721.23 | 665.43 ± 822.30 |
self-reported based on short form of International Physical Activity Questionnaire
| metabolic minutes per week | Maintenance Intervention | Usual Care |
|---|---|---|
| Estimated Metabolic Minutes of Moderate Physical Activity Per Week | 783.40 ± 1175.57 | 810.25 ± 1215.14 |
Collected over 56-week study period. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Maintenance Intervention | — | 4/110 (3.6%) | 0/110 (0%) |
| Usual Care | — | 1/112 (0.9%) | 0/112 (0%) |
| Event | Maintenance Intervention | Usual Care |
|---|---|---|
| Emergency room visit due to high blood pressureCardiac disorders | 1/110 | 0/112 |
| DeathGeneral disorders | 1/110 | 1/112 |
| emergency room visit due to knee painMusculoskeletal and connective tissue disorders | 1/110 | 0/112 |
| Emergency room visit due to anxietyPsychiatric disorders | 1/110 | 0/112 |
| Age, Continuous(years) | Maintenance Intervention | Usual Care | Total |
|---|---|---|---|
| Mean | 61.5 ± 8.3 | 62.0 ± 8.3 | 61.8 ± 8.3 |
| Sex: Female, Male(Participants) | Maintenance Intervention | Usual Care | Total |
|---|---|---|---|
| Female | 17 | 17 | 34 |
| Male | 93 | 95 | 188 |
| Ethnicity (NIH/OMB)(Participants) | Maintenance Intervention | Usual Care | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 2 |
| Not Hispanic or Latino | 105 | 111 | 216 |
| Unknown or Not Reported | 4 | 0 | 4 |
| Race (NIH/OMB)(Participants) | Maintenance Intervention | Usual Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 38 | 45 | 83 |
| White | 67 | 62 | 129 |
| More than one race | 3 | 1 | 4 |
| Unknown or Not Reported | 2 | 3 | 5 |
| Region of Enrollment(participants) | Maintenance Intervention | Usual Care | Total |
|---|---|---|---|
| United States | 110 | 112 | 222 |
| Weight loss during initiation phase(kilograms) | Maintenance Intervention | Usual Care | Total |
|---|---|---|---|
| Mean | 7.2 ± 2.8 | 7.2 ± 3.4 | 7.2 ± 3.1 |
| Weight(kilograms) | Maintenance Intervention | Usual Care | Total |
|---|---|---|---|
| Mean | 102.1 ± 19.8 | 105.0 ± 21.0 | 103.6 ± 20.4 |
| Body mass index(kilograms per meter squared) | Maintenance Intervention | Usual Care | Total |
|---|---|---|---|
| Mean | 33.3 ± 5.7 | 34.6 ± 6.4 | 34.0 ± 6.1 |
3 further baseline measures are reported on the registry.
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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