Innovative Approaches to Weight Loss Show Promise

NEW ORLEANS – Stung by disappointing long-term outcomes for evidence-based intensive behavioral weight loss interventions that are often marked by late backsliding, researchers are turning the standard treatment programs upside down, with encouraging preliminary results.

One example of the new outside-the-box thinking regarding achieving sustained weight loss is the just-completed, 18-month, randomized FRESH START trial. Obese subjects in the novel “maintenance first” study arm spent the first 8 weeks of the intensive 6-month treatment program under orders not to lose any weight. If they did happen to lose a few pounds, they were instructed to gain them right back.

Participants were also encouraged to enjoy their favorite high-fat, high-calorie foods during the initial 8 weeks, albeit mindfully and in moderation, while searching for healthy replacement foods that tasted as good. Toward the end of the 8-week, maintenance-first part of the intervention, participants even took a “vacation week” in which they were instructed to eat five high-fat/high-calorie meals.

Sound counterintuitive? Actually, it’s an approach that’s solidly grounded in behavioral theory, according to Michaela Kiernan, Ph.D., senior research scientist at the center for research in disease prevention at Stanford (Calif.) University.

The emphasis during those first eight weekly 90-minute sessions was on avoiding self-deprivation while mastering the self-monitoring “stability skills” that she and her coinvestigators consider crucial to keeping lost weight off in the long term. The vacation week, for example, afforded an opportunity to practice navigating the dietary disruptions that are inevitable in any weight-loss effort.

In contrast, standard intensive behavioral weight loss programs place the initial emphasis on losing weight; maintenance skills are taught only after the weight loss has already occurred. But that approach hasn’t worked out so well. At the end of the standard, state-of-the-art behavioral and lifestyle intervention, patients have typically lost 15-20 pounds, but they regain 30%-50% of that during the next 12 months. The FRESH START approach was designed to curb that weight regain, she explained at the annual meeting of the Society of Behavioral Medicine.

And it worked. The 267 obese participants in FRESH START were randomized to a maintenance-skills-first group or to a standard, evidence-based, behavioral weight loss program. Both groups got 28 weekly 90-minute group sessions, with identical content for the weight-loss component in both arms. At the end of the intensive 6-month intervention, the mean weight loss was 16.1 pounds in the maintenance-first group, and – as expected – similar at 17.1 pounds in the control arm. But the control group regained 7.0 pounds during the next 12 months, significantly more than the mean 3.0 pounds regained in the maintenance-first arm.

Moreover, nearly twice as many women in the maintenance-first group displayed what behavioral therapists consider a model pattern of weight change: loss of at least 5% of initial weight at 6 months and a gain of less than 5 pounds at any time from 6 to 18 months. This pattern was achieved by 33% in the maintenance-first group, compared with 18% of controls. These FRESH START results have exciting practical as well as theoretical implications for long-term health behavior change, Dr. Kiernan asserted.

Another innovative study presented at the conference took a stepped-care approach to weight loss. The STEP-UP trial was a multicenter, randomized trial involving 363 obese, sedentary subjects who were assigned to a standard, evidence-based, 18-month, group-class behavioral intervention or to a lower-intensity approach in which patients were bumped up to more intensive interventions – phone calls, face-to-face individual counseling, meal replacements – only if they failed to achieve predetermined weight loss goals set at 3-month intervals. Those goals included a 5% weight loss at 3 months, 7% at 6 months, and 10% at 9, 12, and 15 months.

Deborah F. Tate, Ph.D., reported that the two groups achieved similar weight loss at 18 months: an average of 7.6 kg in the standard therapy group and 6.2 kg with the stepped-care approach. Weight loss of at least 5% was achieved among 58% of the control group and 56% of the stepped-care group at 18 months. Blood pressure, resting heart rate, and physical fitness didn’t differ between the two groups at any point.

Although outcomes in the two groups were similar, the costs to achieve those results were not. The stepped-care program cost an average total of $785 for combined payer and participant costs per patient, compared with $1,335 per participant in the standard behavioral therapy group, noted Dr. Tate of the University of North Carolina at Chapel Hill.

The explanation for the substantially lower per-patient total cost in the stepped-care group is that subjects in that study arm achieved their weight loss in an average of 12 group sessions, whereas those in the control arm had an average of 42 sessions. The incremental cost per kilogram of weight loss in the standard program was $409, she added.

Discussant Michael G. Perri, Ph.D., a pioneer in developing intensive behavioral weight loss programs, said he really likes the stepped-care approach because it’s practical and efficient, and it lends itself to implementation in a variety of health care settings.

“I can tell you, one of the biggest barriers to dissemination is that the length and intensity of the kinds of programs we do is too high for adoption in most community settings. We have to find ways to make them more efficient,” said Dr. Perri, professor of clinical and health psychology and dean of the college of public health and health professions at the University of Florida, Gainesville.

Another “terrific” aspect of the STEP-UP trial, he continued, is that the weight loss was achieved with lower cost and markedly fewer sessions than were entailed in standard therapy.

“It tells us that maybe we need to be looking at more of a triage kind of approach: You could set it up so that if somebody doesn’t do well, they get more care, and if they do worse they get even more care. But at some point, I think it really needs to be triage, where we say, ‘Enough is enough – this person is not going to benefit from anything more and we don’t waste more resources on him,’ ” Dr. Perri commented.

As for the FRESH START trial, in which he was a coinvestigator, Dr. Perri raised the possibility that the novel, maintenance-first intervention merely delayed weight regain rather than preventing it. This is suggested by the weight loss trend over time: During months 6-12, the maintenance-first group gained a mean of only 0.4 pounds, whereas in months 12-18, the group put on 2.5 pounds, which wasn’t significantly different from the mean 3.3-pound gain in the control group during that late phase of the study.

Still, delaying weight regain is not to be shrugged off. It confers long-term health benefits, as was recently shown in the 10-year follow-up of the landmark Diabetes Prevention Program (DPP), the psychologist asserted.

The DPP randomized more than 3,000 subjects with impaired glucose tolerance to an intensive diet and exercise lifestyle intervention, to metformin, or to placebo. The results were truly heartening: At 4 years of follow-up, the biggest average weight loss – about 4 kg – was seen in the lifestyle modification group. Moreover, the primary study end point, which was the development of type 2 diabetes, was reduced by 58% in the lifestyle intervention group, compared with placebo, which was a significantly greater benefit than the 31% risk reduction with metformin (N. Engl. J. Med. 2002;346:393-403).

Then came the initially disheartening DPP 10-year follow-up report. At 10 years, there was no longer any difference between the three study arms in terms of weight loss, which stood at about 2 kg in each group. Yet, surprisingly, there was still a 34% reduction in the incidence of type 2 diabetes in the lifestyle arm, compared with placebo, and an 18% reduction with metformin. The incidence was 11.0 cases per 100 person-years with placebo, 7.8 with metformin, and 4.8 with lifestyle modification (Lancet 2009;374:1677-86).

“One of the things that’s instructive about this is that even though we’re worried about the maintenance problem, the DPP shows that if somebody is able to lose weight and keep it off for a few years, that’s likely to have some beneficial impact on their health that can be observed long term, even if they do regain weight,” Dr. Perri observed.

The FRESH START and STEP-UP trials were funded by the National Institutes of Health. Dr. Kiernan, Dr. Tate, and Dr. Perri reported having no financial conflicts.

NEW ORLEANS – Stung by disappointing long-term outcomes for evidence-based intensive behavioral weight loss interventions that are often marked by late backsliding, researchers are turning the standard treatment programs upside down, with encouraging preliminary results.

One example of the new outside-the-box thinking regarding achieving sustained weight loss is the just-completed, 18-month, randomized FRESH START trial. Obese subjects in the novel “maintenance first” study arm spent the first 8 weeks of the intensive 6-month treatment program under orders not to lose any weight. If they did happen to lose a few pounds, they were instructed to gain them right back.

Participants were also encouraged to enjoy their favorite high-fat, high-calorie foods during the initial 8 weeks, albeit mindfully and in moderation, while searching for healthy replacement foods that tasted as good. Toward the end of the 8-week, maintenance-first part of the intervention, participants even took a “vacation week” in which they were instructed to eat five high-fat/high-calorie meals.

Sound counterintuitive? Actually, it’s an approach that’s solidly grounded in behavioral theory, according to Michaela Kiernan, Ph.D., senior research scientist at the center for research in disease prevention at Stanford (Calif.) University.

The emphasis during those first eight weekly 90-minute sessions was on avoiding self-deprivation while mastering the self-monitoring “stability skills” that she and her coinvestigators consider crucial to keeping lost weight off in the long term. The vacation week, for example, afforded an opportunity to practice navigating the dietary disruptions that are inevitable in any weight-loss effort.

In contrast, standard intensive behavioral weight loss programs place the initial emphasis on losing weight; maintenance skills are taught only after the weight loss has already occurred. But that approach hasn’t worked out so well. At the end of the standard, state-of-the-art behavioral and lifestyle intervention, patients have typically lost 15-20 pounds, but they regain 30%-50% of that during the next 12 months. The FRESH START approach was designed to curb that weight regain, she explained at the annual meeting of the Society of Behavioral Medicine.

And it worked. The 267 obese participants in FRESH START were randomized to a maintenance-skills-first group or to a standard, evidence-based, behavioral weight loss program. Both groups got 28 weekly 90-minute group sessions, with identical content for the weight-loss component in both arms. At the end of the intensive 6-month intervention, the mean weight loss was 16.1 pounds in the maintenance-first group, and – as expected – similar at 17.1 pounds in the control arm. But the control group regained 7.0 pounds during the next 12 months, significantly more than the mean 3.0 pounds regained in the maintenance-first arm.

Moreover, nearly twice as many women in the maintenance-first group displayed what behavioral therapists consider a model pattern of weight change: loss of at least 5% of initial weight at 6 months and a gain of less than 5 pounds at any time from 6 to 18 months. This pattern was achieved by 33% in the maintenance-first group, compared with 18% of controls. These FRESH START results have exciting practical as well as theoretical implications for long-term health behavior change, Dr. Kiernan asserted.

Another innovative study presented at the conference took a stepped-care approach to weight loss. The STEP-UP trial was a multicenter, randomized trial involving 363 obese, sedentary subjects who were assigned to a standard, evidence-based, 18-month, group-class behavioral intervention or to a lower-intensity approach in which patients were bumped up to more intensive interventions – phone calls, face-to-face individual counseling, meal replacements – only if they failed to achieve predetermined weight loss goals set at 3-month intervals. Those goals included a 5% weight loss at 3 months, 7% at 6 months, and 10% at 9, 12, and 15 months.

Deborah F. Tate, Ph.D., reported that the two groups achieved similar weight loss at 18 months: an average of 7.6 kg in the standard therapy group and 6.2 kg with the stepped-care approach. Weight loss of at least 5% was achieved among 58% of the control group and 56% of the stepped-care group at 18 months. Blood pressure, resting heart rate, and physical fitness didn’t differ between the two groups at any point.

Although outcomes in the two groups were similar, the costs to achieve those results were not. The stepped-care program cost an average total of $785 for combined payer and participant costs per patient, compared with $1,335 per participant in the standard behavioral therapy group, noted Dr. Tate of the University of North Carolina at Chapel Hill.

The explanation for the substantially lower per-patient total cost in the stepped-care group is that subjects in that study arm achieved their weight loss in an average of 12 group sessions, whereas those in the control arm had an average of 42 sessions. The incremental cost per kilogram of weight loss in the standard program was $409, she added.

Discussant Michael G. Perri, Ph.D., a pioneer in developing intensive behavioral weight loss programs, said he really likes the stepped-care approach because it’s practical and efficient, and it lends itself to implementation in a variety of health care settings.

“I can tell you, one of the biggest barriers to dissemination is that the length and intensity of the kinds of programs we do is too high for adoption in most community settings. We have to find ways to make them more efficient,” said Dr. Perri, professor of clinical and health psychology and dean of the college of public health and health professions at the University of Florida, Gainesville.

Another “terrific” aspect of the STEP-UP trial, he continued, is that the weight loss was achieved with lower cost and markedly fewer sessions than were entailed in standard therapy.

“It tells us that maybe we need to be looking at more of a triage kind of approach: You could set it up so that if somebody doesn’t do well, they get more care, and if they do worse they get even more care. But at some point, I think it really needs to be triage, where we say, ‘Enough is enough – this person is not going to benefit from anything more and we don’t waste more resources on him,’ ” Dr. Perri commented.

As for the FRESH START trial, in which he was a coinvestigator, Dr. Perri raised the possibility that the novel, maintenance-first intervention merely delayed weight regain rather than preventing it. This is suggested by the weight loss trend over time: During months 6-12, the maintenance-first group gained a mean of only 0.4 pounds, whereas in months 12-18, the group put on 2.5 pounds, which wasn’t significantly different from the mean 3.3-pound gain in the control group during that late phase of the study.

Still, delaying weight regain is not to be shrugged off. It confers long-term health benefits, as was recently shown in the 10-year follow-up of the landmark Diabetes Prevention Program (DPP), the psychologist asserted.

The DPP randomized more than 3,000 subjects with impaired glucose tolerance to an intensive diet and exercise lifestyle intervention, to metformin, or to placebo. The results were truly heartening: At 4 years of follow-up, the biggest average weight loss – about 4 kg – was seen in the lifestyle modification group. Moreover, the primary study end point, which was the development of type 2 diabetes, was reduced by 58% in the lifestyle intervention group, compared with placebo, which was a significantly greater benefit than the 31% risk reduction with metformin (N. Engl. J. Med. 2002;346:393-403).

Then came the initially disheartening DPP 10-year follow-up report. At 10 years, there was no longer any difference between the three study arms in terms of weight loss, which stood at about 2 kg in each group. Yet, surprisingly, there was still a 34% reduction in the incidence of type 2 diabetes in the lifestyle arm, compared with placebo, and an 18% reduction with metformin. The incidence was 11.0 cases per 100 person-years with placebo, 7.8 with metformin, and 4.8 with lifestyle modification (Lancet 2009;374:1677-86).

“One of the things that’s instructive about this is that even though we’re worried about the maintenance problem, the DPP shows that if somebody is able to lose weight and keep it off for a few years, that’s likely to have some beneficial impact on their health that can be observed long term, even if they do regain weight,” Dr. Perri observed.

The FRESH START and STEP-UP trials were funded by the National Institutes of Health. Dr. Kiernan, Dr. Tate, and Dr. Perri reported having no financial conflicts.

NEW ORLEANS – Stung by disappointing long-term outcomes for evidence-based intensive behavioral weight loss interventions that are often marked by late backsliding, researchers are turning the standard treatment programs upside down, with encouraging preliminary results.

One example of the new outside-the-box thinking regarding achieving sustained weight loss is the just-completed, 18-month, randomized FRESH START trial. Obese subjects in the novel “maintenance first” study arm spent the first 8 weeks of the intensive 6-month treatment program under orders not to lose any weight. If they did happen to lose a few pounds, they were instructed to gain them right back.

Participants were also encouraged to enjoy their favorite high-fat, high-calorie foods during the initial 8 weeks, albeit mindfully and in moderation, while searching for healthy replacement foods that tasted as good. Toward the end of the 8-week, maintenance-first part of the intervention, participants even took a “vacation week” in which they were instructed to eat five high-fat/high-calorie meals.

Sound counterintuitive? Actually, it’s an approach that’s solidly grounded in behavioral theory, according to Michaela Kiernan, Ph.D., senior research scientist at the center for research in disease prevention at Stanford (Calif.) University.

The emphasis during those first eight weekly 90-minute sessions was on avoiding self-deprivation while mastering the self-monitoring “stability skills” that she and her coinvestigators consider crucial to keeping lost weight off in the long term. The vacation week, for example, afforded an opportunity to practice navigating the dietary disruptions that are inevitable in any weight-loss effort.

In contrast, standard intensive behavioral weight loss programs place the initial emphasis on losing weight; maintenance skills are taught only after the weight loss has already occurred. But that approach hasn’t worked out so well. At the end of the standard, state-of-the-art behavioral and lifestyle intervention, patients have typically lost 15-20 pounds, but they regain 30%-50% of that during the next 12 months. The FRESH START approach was designed to curb that weight regain, she explained at the annual meeting of the Society of Behavioral Medicine.

And it worked. The 267 obese participants in FRESH START were randomized to a maintenance-skills-first group or to a standard, evidence-based, behavioral weight loss program. Both groups got 28 weekly 90-minute group sessions, with identical content for the weight-loss component in both arms. At the end of the intensive 6-month intervention, the mean weight loss was 16.1 pounds in the maintenance-first group, and – as expected – similar at 17.1 pounds in the control arm. But the control group regained 7.0 pounds during the next 12 months, significantly more than the mean 3.0 pounds regained in the maintenance-first arm.

Moreover, nearly twice as many women in the maintenance-first group displayed what behavioral therapists consider a model pattern of weight change: loss of at least 5% of initial weight at 6 months and a gain of less than 5 pounds at any time from 6 to 18 months. This pattern was achieved by 33% in the maintenance-first group, compared with 18% of controls. These FRESH START results have exciting practical as well as theoretical implications for long-term health behavior change, Dr. Kiernan asserted.

Another innovative study presented at the conference took a stepped-care approach to weight loss. The STEP-UP trial was a multicenter, randomized trial involving 363 obese, sedentary subjects who were assigned to a standard, evidence-based, 18-month, group-class behavioral intervention or to a lower-intensity approach in which patients were bumped up to more intensive interventions – phone calls, face-to-face individual counseling, meal replacements – only if they failed to achieve predetermined weight loss goals set at 3-month intervals. Those goals included a 5% weight loss at 3 months, 7% at 6 months, and 10% at 9, 12, and 15 months.

Deborah F. Tate, Ph.D., reported that the two groups achieved similar weight loss at 18 months: an average of 7.6 kg in the standard therapy group and 6.2 kg with the stepped-care approach. Weight loss of at least 5% was achieved among 58% of the control group and 56% of the stepped-care group at 18 months. Blood pressure, resting heart rate, and physical fitness didn’t differ between the two groups at any point.

Although outcomes in the two groups were similar, the costs to achieve those results were not. The stepped-care program cost an average total of $785 for combined payer and participant costs per patient, compared with $1,335 per participant in the standard behavioral therapy group, noted Dr. Tate of the University of North Carolina at Chapel Hill.

The explanation for the substantially lower per-patient total cost in the stepped-care group is that subjects in that study arm achieved their weight loss in an average of 12 group sessions, whereas those in the control arm had an average of 42 sessions. The incremental cost per kilogram of weight loss in the standard program was $409, she added.

Discussant Michael G. Perri, Ph.D., a pioneer in developing intensive behavioral weight loss programs, said he really likes the stepped-care approach because it’s practical and efficient, and it lends itself to implementation in a variety of health care settings.

“I can tell you, one of the biggest barriers to dissemination is that the length and intensity of the kinds of programs we do is too high for adoption in most community settings. We have to find ways to make them more efficient,” said Dr. Perri, professor of clinical and health psychology and dean of the college of public health and health professions at the University of Florida, Gainesville.

Another “terrific” aspect of the STEP-UP trial, he continued, is that the weight loss was achieved with lower cost and markedly fewer sessions than were entailed in standard therapy.

“It tells us that maybe we need to be looking at more of a triage kind of approach: You could set it up so that if somebody doesn’t do well, they get more care, and if they do worse they get even more care. But at some point, I think it really needs to be triage, where we say, ‘Enough is enough – this person is not going to benefit from anything more and we don’t waste more resources on him,’ ” Dr. Perri commented.

As for the FRESH START trial, in which he was a coinvestigator, Dr. Perri raised the possibility that the novel, maintenance-first intervention merely delayed weight regain rather than preventing it. This is suggested by the weight loss trend over time: During months 6-12, the maintenance-first group gained a mean of only 0.4 pounds, whereas in months 12-18, the group put on 2.5 pounds, which wasn’t significantly different from the mean 3.3-pound gain in the control group during that late phase of the study.

Still, delaying weight regain is not to be shrugged off. It confers long-term health benefits, as was recently shown in the 10-year follow-up of the landmark Diabetes Prevention Program (DPP), the psychologist asserted.

The DPP randomized more than 3,000 subjects with impaired glucose tolerance to an intensive diet and exercise lifestyle intervention, to metformin, or to placebo. The results were truly heartening: At 4 years of follow-up, the biggest average weight loss – about 4 kg – was seen in the lifestyle modification group. Moreover, the primary study end point, which was the development of type 2 diabetes, was reduced by 58% in the lifestyle intervention group, compared with placebo, which was a significantly greater benefit than the 31% risk reduction with metformin (N. Engl. J. Med. 2002;346:393-403).

Then came the initially disheartening DPP 10-year follow-up report. At 10 years, there was no longer any difference between the three study arms in terms of weight loss, which stood at about 2 kg in each group. Yet, surprisingly, there was still a 34% reduction in the incidence of type 2 diabetes in the lifestyle arm, compared with placebo, and an 18% reduction with metformin. The incidence was 11.0 cases per 100 person-years with placebo, 7.8 with metformin, and 4.8 with lifestyle modification (Lancet 2009;374:1677-86).

“One of the things that’s instructive about this is that even though we’re worried about the maintenance problem, the DPP shows that if somebody is able to lose weight and keep it off for a few years, that’s likely to have some beneficial impact on their health that can be observed long term, even if they do regain weight,” Dr. Perri observed.

The FRESH START and STEP-UP trials were funded by the National Institutes of Health. Dr. Kiernan, Dr. Tate, and Dr. Perri reported having no financial conflicts.