Cardiovascular DiseasesNCT00005686
Dietary Intervention Methods for Clinical Trials
An observational study of Cardiovascular Diseases and Heart Diseases, run by University of Minnesota.
Trial summary
To develop a dietary intervention method that was capable of producing large sustained weight losses and was thus suitable for use in clinical trials related to obesity. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Obesity
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Apr 1989to Apr 2003
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To develop a dietary intervention method that was capable of producing large sustained weight losses and was thus suitable for use in clinical trials related to obesity.
Read the detailed description
BACKGROUND:
A study by the investigators showed that a method based on principles of antecedent control, namely the provision of food to participants, was successful in almost doubling weight losses over a twelve month period compared to those attained in a standard behavioral weight control program. These weight losses were associated with substantial improvements in cardiovascular risk factors.
DESIGN NARRATIVE:
There were several studies in this two-center project (R01HL41330 and R01HL41332). Obese subjects, male and female, were recruited at the University of Pittsburgh and the University of Minnesota. The subjects were randomly assigned to one of five treatment groups: no treatment control, standard behavioral nutrition program, standard program with incentives, standard program with food provision, and standard program with both incentives and food provision. The effectiveness of the treatments was analyzed by assessing changes in body weight, coronary heart disease risk factors (lipids, blood pressure, insulin, and glucose) and process variables (eating and exercise behavior, knowledge, barriers to adherence) at six month intervals for eighteen months.
The project was renewed in April 1992 and included four studies. Study 1 determined whether there were long-term benefits to food provision by reexamining the 202 participants in the original study one year after the end of treatment. Study 2 investigated the factors related to the successful food provision intervention by comparing the additive effects of standard behavioral treatment and the three central components of food provision: structured meal plans, prepackaged food and subsidy of the food. It also explored theoretical mechanisms which might underlie the food provision effect, specifically decision making and stimulus control. Study 3 evaluated the effectiveness of extending the food provision methodology to families. Overweight spouse pairs were randomized to treatments in which either one member of the pair participated in treatment and received food, or both members of the pair participated and were provided with food. Study 4 determined whether the principles of antecedent control could also be applied to exercise. Participants were randomized to weight control programs which included either the usual exercise instructions or structured plans for exercise and free passes to exercise facilities near their home. It was hypothesized that providing food for the obese spouse as well as the patient, and providing antecedent control for exercise through structured plans and free passes would both improve the maintenance of weight loss.
The studies were renewed in FY 1998 through April, 2002 to compare the long-term weight losses achieved in a standard behavioral program with those obtained in an enhanced exercise intervention. The exercise goal in the standard program was 1000 kcal/week, while that in the enhanced exercise program was 2500 kcal/week. The study was conducted with 180 subjects divided equally between men and women, half recruited in Minneapolis and the other half in Pittsburgh. The primary hypotheses were that the enhanced exercise intervention group would have significantly greater weight losses than the standard intervention group at the end of the 18 month treatment program and at the 30-month follow-up. In addition, the two conditions were compared at 0, 6, 12, 18, and 30 months with regard to exercise levels, variables that might be related to exercise and weight loss, and measures related to quality of life. Furthermore, the investigators attempted to determine predictors of long-term weight loss and exercise behavior, and examined the effects of social support on exercise level and weight loss of the enhanced exercise intervention group.
Include both R01HL41330 and R01HL41332.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Obesity
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Obesity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startApr 1989
- Study completionApr 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Investigators
- Robert Jeffery, University of MinnesotaRena Wing, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005686
- Sponsor's protocol ID
- 4171
- Other IDs
- R01HL041332
- Status last verified
- Feb 2016
- First submitted
- 25 May 2000
- Last updated
- 1 Mar 2016
- Results posted
- No
Publications
Wing RR. Physical activity in the treatment of the adulthood overweight and obesity: current evidence and research issues. Med Sci Sports Exerc. 1999 Nov;31(11 Suppl):S547-52. doi: 10.1097/00005768-199911001-00010.
PubMed 10593526Wing RR, Jeffery RW. Benefits of recruiting participants with friends and increasing social support for weight loss and maintenance. J Consult Clin Psychol. 1999 Feb;67(1):132-8. doi: 10.1037//0022-006x.67.1.132.
PubMed 10028217Jeffery RW, Wing RR, Thorson C, Burton LR. Use of personal trainers and financial incentives to increase exercise in a behavioral weight-loss program. J Consult Clin Psychol. 1998 Oct;66(5):777-83. doi: 10.1037//0022-006x.66.5.777.
PubMed 9803696Jeffery RW, Wing RR, Mayer RR. Are smaller weight losses or more achievable weight loss goals better in the long term for obese patients? J Consult Clin Psychol. 1998 Aug;66(4):641-5. doi: 10.1037//0022-006x.66.4.641.
PubMed 9735580Wirfalt AK, Jeffery RW. Using cluster analysis to examine dietary patterns: nutrient intakes, gender, and weight status differ across food pattern clusters. J Am Diet Assoc. 1997 Mar;97(3):272-9. doi: 10.1016/s0002-8223(97)00071-0.
PubMed 9060944Wing RR. Insulin sensitivity as a predictor of weight regain. Obes Res. 1997 Jan;5(1):24-9. doi: 10.1002/j.1550-8528.1997.tb00279.x.
PubMed 9061712Wing RR, Sinha MK, Considine RV, Lang W, Caro JF. Relationship between weight loss maintenance and changes in serum leptin levels. Horm Metab Res. 1996 Dec;28(12):698-703. doi: 10.1055/s-2007-979881.
PubMed 9013745Wing RR, Jeffery RW, Pronk N, Hellerstedt WL. Effects of a personal trainer and financial incentives on exercise adherence in overweight women in a behavioral weight loss program. Obes Res. 1996 Sep;4(5):457-62. doi: 10.1002/j.1550-8528.1996.tb00254.x.
PubMed 8885210Jeffery RW, Wing RR. Long-term effects of interventions for weight loss using food provision and monetary incentives. J Consult Clin Psychol. 1995 Oct;63(5):793-6. doi: 10.1037//0022-006x.63.5.793.
PubMed 7593872Wing RR. Changing diet and exercise behaviors in individuals at risk for weight gain. Obes Res. 1995 Sep;3 Suppl 2:277s-282s. doi: 10.1002/j.1550-8528.1995.tb00474.x.
PubMed 8581787Wing RR, Jeffery RW, Hellerstedt WL. A prospective study of effects of weight cycling on cardiovascular risk factors. Arch Intern Med. 1995 Jul 10;155(13):1416-22.
PubMed 7794091Wing RR, Jeffery RW. Effect of modest weight loss on changes in cardiovascular risk factors: are there differences between men and women or between weight loss and maintenance? Int J Obes Relat Metab Disord. 1995 Jan;19(1):67-73.
PubMed 7719395French SA, Jeffery RW, Wing RR. Sex differences among participants in a weight-control program. Addict Behav. 1994 Mar-Apr;19(2):147-58. doi: 10.1016/0306-4603(94)90039-6.
PubMed 8036962Jeffery RW, Wing RR, Thorson C, Burton LR, Raether C, Harvey J, Mullen M. Strengthening behavioral interventions for weight loss: a randomized trial of food provision and monetary incentives. J Consult Clin Psychol. 1993 Dec;61(6):1038-45. doi: 10.1037//0022-006x.61.6.1038.
PubMed 8113481Bunker CH, Wing RR, Becker DJ, Kuller LH. Sodium-lithium countertransport activity is decreased after weight loss in healthy obese men. Metabolism. 1993 Aug;42(8):1052-8. doi: 10.1016/0026-0495(93)90022-g.
PubMed 8345810
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Intervention Methods for Clinical Trials
- ClinicalTrials.gov ID
- NCT00005686
- Acronym / sponsor ID
- 4171
- Conditions
- Cardiovascular Diseases, Heart Diseases, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Apr 1989
- Study completion
- Apr 2003
- First posted
- 26 May 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To develop a dietary intervention method that was capable of producing large sustained weight losses and was thus suitable for use in clinical trials related to obesity.
Detailed description
BACKGROUND:
A study by the investigators showed that a method based on principles of antecedent control, namely the provision of food to participants, was successful in almost doubling weight losses over a twelve month period compared to those attained in a standard behavioral weight control program. These weight losses were associated with substantial improvements in cardiovascular risk factors.
DESIGN NARRATIVE:
There were several studies in this two-center project (R01HL41330 and R01HL41332). Obese subjects, male and female, were recruited at the University of Pittsburgh and the University of Minnesota. The subjects were randomly assigned to one of five treatment groups: no treatment control, standard behavioral nutrition program, standard program with incentives, standard program with food provision, and standard program with both incentives and food provision. The effectiveness of the treatments was analyzed by assessing changes in body weight, coronary heart disease risk factors (lipids, blood pressure, insulin, and glucose) and process variables (eating and exercise behavior, knowledge, barriers to adherence) at six month intervals for eighteen months.
The project was renewed in April 1992 and included four studies. Study 1 determined whether there were long-term benefits to food provision by reexamining the 202 participants in the original study one year after the end of treatment. Study 2 investigated the factors related to the successful food provision intervention by comparing the additive effects of standard behavioral treatment and the three central components of food provision: structured meal plans, prepackaged food and subsidy of the food. It also explored theoretical mechanisms which might underlie the food provision effect, specifically decision making and stimulus control. Study 3 evaluated the effectiveness of extending the food provision methodology to families. Overweight spouse pairs were randomized to treatments in which either one member of the pair participated in treatment and received food, or both members of the pair participated and were provided with food. Study 4 determined whether the principles of antecedent control could also be applied to exercise. Participants were randomized to weight control programs which included either the usual exercise instructions or structured plans for exercise and free passes to exercise facilities near their home. It was hypothesized that providing food for the obese spouse as well as the patient, and providing antecedent control for exercise through structured plans and free passes would both improve the maintenance of weight loss.
The studies were renewed in FY 1998 through April, 2002 to compare the long-term weight losses achieved in a standard behavioral program with those obtained in an enhanced exercise intervention. The exercise goal in the standard program was 1000 kcal/week, while that in the enhanced exercise program was 2500 kcal/week. The study was conducted with 180 subjects divided equally between men and women, half recruited in Minneapolis and the other half in Pittsburgh. The primary hypotheses were that the enhanced exercise intervention group would have significantly greater weight losses than the standard intervention group at the end of the 18 month treatment program and at the 30-month follow-up. In addition, the two conditions were compared at 0, 6, 12, 18, and 30 months with regard to exercise levels, variables that might be related to exercise and weight loss, and measures related to quality of life. Furthermore, the investigators attempted to determine predictors of long-term weight loss and exercise behavior, and examined the effects of social support on exercise level and weight loss of the enhanced exercise intervention group.
Include both R01HL41330 and R01HL41332.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2016.
- Background: PubMed 10593526Wing RR. Physical activity in the treatment of the adulthood overweight and obesity: current evidence and research issues. Med Sci Sports Exerc. 1999 Nov;31(11 Suppl):S547-52. doi: 10.1097/00005768-199911001-00010.
- Background: PubMed 10028217Wing RR, Jeffery RW. Benefits of recruiting participants with friends and increasing social support for weight loss and maintenance. J Consult Clin Psychol. 1999 Feb;67(1):132-8. doi: 10.1037//0022-006x.67.1.132.
- Background: PubMed 9803696Jeffery RW, Wing RR, Thorson C, Burton LR. Use of personal trainers and financial incentives to increase exercise in a behavioral weight-loss program. J Consult Clin Psychol. 1998 Oct;66(5):777-83. doi: 10.1037//0022-006x.66.5.777.
- Background: PubMed 9735580Jeffery RW, Wing RR, Mayer RR. Are smaller weight losses or more achievable weight loss goals better in the long term for obese patients? J Consult Clin Psychol. 1998 Aug;66(4):641-5. doi: 10.1037//0022-006x.66.4.641.
- Background: PubMed 9060944Wirfalt AK, Jeffery RW. Using cluster analysis to examine dietary patterns: nutrient intakes, gender, and weight status differ across food pattern clusters. J Am Diet Assoc. 1997 Mar;97(3):272-9. doi: 10.1016/s0002-8223(97)00071-0.
- Background: PubMed 9061712Wing RR. Insulin sensitivity as a predictor of weight regain. Obes Res. 1997 Jan;5(1):24-9. doi: 10.1002/j.1550-8528.1997.tb00279.x.
- Background: PubMed 9013745Wing RR, Sinha MK, Considine RV, Lang W, Caro JF. Relationship between weight loss maintenance and changes in serum leptin levels. Horm Metab Res. 1996 Dec;28(12):698-703. doi: 10.1055/s-2007-979881.
- Background: PubMed 8885210Wing RR, Jeffery RW, Pronk N, Hellerstedt WL. Effects of a personal trainer and financial incentives on exercise adherence in overweight women in a behavioral weight loss program. Obes Res. 1996 Sep;4(5):457-62. doi: 10.1002/j.1550-8528.1996.tb00254.x.
- Background: PubMed 7593872Jeffery RW, Wing RR. Long-term effects of interventions for weight loss using food provision and monetary incentives. J Consult Clin Psychol. 1995 Oct;63(5):793-6. doi: 10.1037//0022-006x.63.5.793.
- Background: PubMed 8581787Wing RR. Changing diet and exercise behaviors in individuals at risk for weight gain. Obes Res. 1995 Sep;3 Suppl 2:277s-282s. doi: 10.1002/j.1550-8528.1995.tb00474.x.
- Background: PubMed 7794091Wing RR, Jeffery RW, Hellerstedt WL. A prospective study of effects of weight cycling on cardiovascular risk factors. Arch Intern Med. 1995 Jul 10;155(13):1416-22.
- Background: PubMed 7719395Wing RR, Jeffery RW. Effect of modest weight loss on changes in cardiovascular risk factors: are there differences between men and women or between weight loss and maintenance? Int J Obes Relat Metab Disord. 1995 Jan;19(1):67-73.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Jeffery
University of Minnesota
Rena Wing
The Miriam Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by University of Minnesota.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005686, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2016.