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Total meal replacement intervention decreases nonresponsiveness in obesity

NASHVILLE, Tenn. — A behavioral weight-loss intervention using total meal replacement decreased the odds of nonresponsiveness by 60% after 1 year vs. a standard food-based intervention, according to study data presented here.

In an analysis of the OPTIWIN study, researchers also found that the OPTIFAST program was effective vs. an active control intervention providing the current standard-of-care behavior and lifestyle treatment for obesity.

Jamy D. Ard

“The OPTIWIN study is a contemporary test of how well people do with a program like OPTIFAST that uses total meal replacement as the active weight-loss treatment to help people lose weight and then keep that weight off over a year,” Jamy D. Ard, MD, associate professor in the department of epidemiology and prevention and the department of medicine at Wake Forest University in Winston-Salem, North Carolina, told Endocrine Today. “People have nearly a doubled weight-loss effect compared with food-based programs in that 1-year time frame. The other takeaway is that the percentage of people who respond to treatment [with total meal replacement] is much higher.”

In an open-label, randomized trial, Ard and colleagues analyzed data from 273 nonsmoking adults with a BMI between 30 kg/m² and 55 kg/m² with no recent history of weight loss, stratified by type 2 diabetes status. Researchers randomly assigned participants to total meal replacement with the OPTIFAST weight management, including shakes, soups and bars delivering 160 kcal to 230 kcal per serving (n = 135), or to a food-based eating plan (n = 138) for 52 weeks. During the active weight-loss phase (weeks 1-26), participants in the total meal replacement group were assigned to a diet of up to 800 kcal per day for up to 16 weeks, followed by a gradual reintroduction of food through week 26. The food-based group was assigned to a reduced-energy diet of 500 kcal to 750 kcal per day below estimated total energy expenditure. During weeks 27 to 52, the total meal replacement group received one to two meal replacements daily, plus food, to achieve maintenance, whereas the food-based group adjusted energy intake to achieve maintenance.

Primary outcome was nonresponse, defined as less than 3% of baseline weight lost at any follow-up time point. Researchers used a repeated logistic regression model that included fixed visit effect, fixed treatment effect, fixed baseline body weight effect, treatment-by-visit interaction and confounders (age, race, site and diabetes status) to assess group differences in nonresponse.

Researchers found that the frequency of nonresponders was lower in the total meal replacement group vs. the food-based group at follow-up and at all time points.

At 12 weeks, the OR for nonresponsiveness for a person in the total meal replacement group was 0.23 (95% CI, 0.12-0.45) compared with a participant in the food-based group. Results persisted at 26 weeks, with an OR of 0.28 for nonresponsiveness among total meal replacement participants vs. food-based participants (95% CI, 0.15-0.52). At 52 weeks, OR for nonresponsiveness was 0.4 for participants in the meal replacement group vs. the food-based group (95% CI, 0.23-0.71).

The tolerability and safety of the program is very good when compared with a food-based strategy, Ard said.

“This helps to provide another tool for providers to recommend or use with their patients for weight loss, when we just don’t have a lot of options for people,” he said.

On average, responders in the OPTIFAST group consumed more meal replacements vs. nonresponders, according to the researchers. Additionally, Ard said, the convenience of total meal replacement makes it an attractive option for some patients, who often struggle with food-based interventions.

“Meal replacement makes it really simple,” he said. “You eat what’s in the box. You drink what’s in the box. Being able to have that behavior reinforced, that becomes important in terms of helping sustain the behavior over a period of time.”

Program support and frequent check-ins with a health care provider are also key, Ard said, adding that OPTIFAST was multidisciplinary.

“Those things do make a difference,” he said. – by Regina Schaffer

Reference:

Ard JD, et al. T-P3127. Presented at: ObesityWeek 2018; Nov. 11-15, 2018; Nashville, Tenn.

For more information:

Jamy D. Ard, MD, can be reached at Wake Forest School of Medicine, Bowman Gray Center, 475 Vine St., Winston-Salem, NC 27101; email: jard@wakehealth.edu.

Disclosure: Nestle Health Science sponsored this study.

NASHVILLE, Tenn. — A behavioral weight-loss intervention using total meal replacement decreased the odds of nonresponsiveness by 60% after 1 year vs. a standard food-based intervention, according to study data presented here.

In an analysis of the OPTIWIN study, researchers also found that the OPTIFAST program was effective vs. an active control intervention providing the current standard-of-care behavior and lifestyle treatment for obesity.

Jamy D. Ard

“The OPTIWIN study is a contemporary test of how well people do with a program like OPTIFAST that uses total meal replacement as the active weight-loss treatment to help people lose weight and then keep that weight off over a year,” Jamy D. Ard, MD, associate professor in the department of epidemiology and prevention and the department of medicine at Wake Forest University in Winston-Salem, North Carolina, told Endocrine Today. “People have nearly a doubled weight-loss effect compared with food-based programs in that 1-year time frame. The other takeaway is that the percentage of people who respond to treatment [with total meal replacement] is much higher.”

In an open-label, randomized trial, Ard and colleagues analyzed data from 273 nonsmoking adults with a BMI between 30 kg/m² and 55 kg/m² with no recent history of weight loss, stratified by type 2 diabetes status. Researchers randomly assigned participants to total meal replacement with the OPTIFAST weight management, including shakes, soups and bars delivering 160 kcal to 230 kcal per serving (n = 135), or to a food-based eating plan (n = 138) for 52 weeks. During the active weight-loss phase (weeks 1-26), participants in the total meal replacement group were assigned to a diet of up to 800 kcal per day for up to 16 weeks, followed by a gradual reintroduction of food through week 26. The food-based group was assigned to a reduced-energy diet of 500 kcal to 750 kcal per day below estimated total energy expenditure. During weeks 27 to 52, the total meal replacement group received one to two meal replacements daily, plus food, to achieve maintenance, whereas the food-based group adjusted energy intake to achieve maintenance.

Primary outcome was nonresponse, defined as less than 3% of baseline weight lost at any follow-up time point. Researchers used a repeated logistic regression model that included fixed visit effect, fixed treatment effect, fixed baseline body weight effect, treatment-by-visit interaction and confounders (age, race, site and diabetes status) to assess group differences in nonresponse.

Researchers found that the frequency of nonresponders was lower in the total meal replacement group vs. the food-based group at follow-up and at all time points.

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At 12 weeks, the OR for nonresponsiveness for a person in the total meal replacement group was 0.23 (95% CI, 0.12-0.45) compared with a participant in the food-based group. Results persisted at 26 weeks, with an OR of 0.28 for nonresponsiveness among total meal replacement participants vs. food-based participants (95% CI, 0.15-0.52). At 52 weeks, OR for nonresponsiveness was 0.4 for participants in the meal replacement group vs. the food-based group (95% CI, 0.23-0.71).

The tolerability and safety of the program is very good when compared with a food-based strategy, Ard said.

“This helps to provide another tool for providers to recommend or use with their patients for weight loss, when we just don’t have a lot of options for people,” he said.

On average, responders in the OPTIFAST group consumed more meal replacements vs. nonresponders, according to the researchers. Additionally, Ard said, the convenience of total meal replacement makes it an attractive option for some patients, who often struggle with food-based interventions.

“Meal replacement makes it really simple,” he said. “You eat what’s in the box. You drink what’s in the box. Being able to have that behavior reinforced, that becomes important in terms of helping sustain the behavior over a period of time.”

Program support and frequent check-ins with a health care provider are also key, Ard said, adding that OPTIFAST was multidisciplinary.

“Those things do make a difference,” he said. – by Regina Schaffer

Reference:

Ard JD, et al. T-P3127. Presented at: ObesityWeek 2018; Nov. 11-15, 2018; Nashville, Tenn.

For more information:

Jamy D. Ard, MD, can be reached at Wake Forest School of Medicine, Bowman Gray Center, 475 Vine St., Winston-Salem, NC 27101; email: jard@wakehealth.edu.

Disclosure: Nestle Health Science sponsored this study.

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